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Tuesday, September 13, 2016

Lantus

Generic Name: insulin glargine, recombinant (Subcutaneous route)

IN-su-lin GLAR-jeen, ree-KOM-bi-nant

Commonly used brand name(s)

In the U.S.

Lantus

Lantus SoloStar

Available Dosage Forms:

Solution

Therapeutic Class: Antidiabetic

Pharmacologic Class: Insulin, Long Acting

Uses For Lantus

Insulin glargine is a type of insulin. Insulin is one of many hormones that help the body turn the food we eat into energy. This is done by using the glucose (sugar) in the blood as quick energy. Also, insulin helps us store energy that we can use later. When you have type 2 diabetes mellitus, your body does not produce enough insulin, or the insulin produced is not used properly. This causes you to have too much sugar in your blood. Like other types of insulin, insulin glargine is used to keep your blood sugar level close to normal. Insulin glargine is a long-acting insulin that works slowly over about 24 hours. You may have to use insulin glargine in combination with another type of insulin or with a type of oral diabetes medicine to keep your blood sugar under control.

This medicine is available only with your doctor's prescription.

Before Using Lantus

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

This medicine has been tested in a limited number of children 6 years of age or older. In effective doses, the medicine has not been shown to cause different side effects or problems than it does in adults.

Geriatric

This medicine has been tested in a limited number of patients 65 years of age or older and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of insulin glargine, recombinant

This section provides information on the proper use of a number of products that contain insulin glargine, recombinant. It may not be specific to Lantus. Please read with care.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Each package of insulin glargine contains a patient information sheet. Read this sheet carefully and make sure you understand:

How to prepare the medicine.

How to inject the medicine.

How to dispose of syringes, needles, and injection devices.

It is best to use a different place on the body for each injection (e.g., abdomen, thigh, or upper arm). If you have questions about this, contact a member of your health care team.

Since insulin glargine lowers the blood glucose over 24 hours, it should be taken once daily at bedtime

Follow carefully the special meal plan your doctor gave you. This is the most important part of controlling your condition, and is necessary if the medicine is to work properly. Also, exercise regularly and test for sugar in your blood or urine as directed.

For injection dosage form:
- For type 2 diabetes mellitus:
  - Adults, teenagers, and children 6 years of age or older—The dose is based on your blood sugar and must be determined by your doctor.
  - Children up to 6 years of age—Use and dose must be determined by your doctor.

Storage

Store in the refrigerator. Do not freeze.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

After a cartridge has been inserted into a pen, store the cartridge and pen at room temperature, not in the refrigerator.

Precautions While Using Lantus

Never share insulin pens or cartridges with others under any circumstances. It is not safe for one pen to be used for more than one person. Sharing needles or pens can result in transmission of hepatitis viruses, HIV, or other blood-borne illnesses.

Your doctor will want to check your progress at regular visits, especially during the first few weeks you take this medicine.

It is very important to follow carefully any instructions from your health care team about:

Alcohol—Drinking alcohol may cause severe low blood sugar. Discuss this with your health care team.

Other medicines—Do not take other medicines during the time you are taking insulin glargine unless they have been discussed with your doctor. This especially includes nonprescription medicines such as aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems.

Counseling—Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, patients with diabetes may need special counseling about diabetes medicine dosing changes that might occur because of lifestyle changes, such as changes in exercise and diet. Furthermore, counseling on contraception and pregnancy is needed because of the problems that can occur in patients with diabetes during pregnancy.

Travel—Keep a recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times.

In case of emergency—There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to:

Wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says that you have diabetes and a list of all of your medicines.

Keep an extra supply of insulin glargine and syringes with needles or injection devices on hand in case high blood sugar occurs.

Keep some kind of quick-acting sugar handy to treat low blood sugar.

Have a glucagon kit and a syringe and needle available in case severe low blood sugar occurs. Check and replace any expired kits regularly.

Too much insulin glargine can cause hypoglycemia (low blood sugar). Low blood sugar also can occur if you use insulin glargine with another antidiabetic medicine, delay or miss a meal or snack, exercise more than usual, or drink alcohol. Symptoms of low blood sugar must be treated before they lead to unconsciousness (passing out). Different people may feel different symptoms of low blood sugar. It is important that you learn which symptoms of low blood sugar you usually have so that you can treat it quickly.

Symptoms of low blood sugar include anxiety; behavior change similar to being drunk; blurred vision; cold sweats; confusion; difficulty in thinking; dizziness or lightheadedness; drowsiness; excessive hunger; fast heartbeat; headache; irritability or abnormal behavior; nervousness; nightmares; restless sleep; shakiness; slurred speech; and tingling in the hands, feet, lips, or tongue.

If symptoms of low blood sugar occur, eat glucose tablets or gel, corn syrup, honey, or sugar cubes; or drink fruit juice, nondiet soft drink, or sugar dissolved in water to relieve the symptoms. Also, check your blood for low blood sugar. Get to a doctor or a hospital right away if the symptoms do not improve. Someone should call for emergency help immediately if severe symptoms such as convulsions (seizures) or unconsciousness occur. Have a glucagon kit available, along with a syringe and needle, and know how to use it. Members of your household also should know how to use it.

Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your antidiabetic medicine, overeat or do not follow your meal plan, have emotional stress or infection, or do not exercise as much as usual.

Symptoms of high blood sugar include blurred vision; drowsiness; dry mouth; flushed, dry skin; fruit-like breath odor; increased urination; ketones in urine; loss of appetite; stomachache, nausea, or vomiting; tiredness; troubled breathing (rapid and deep); unconsciousness; and unusual thirst.

If symptoms of high blood sugar occur, check your blood sugar level and then call your doctor for instructions.

Lantus Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Convulsions (seizures)

unconsciousness

Check with your doctor as soon as possible if any of the following side effects occur:

More common

Low blood sugar, including anxious feeling; behavior change similar to being drunk; blurred vision; cold sweats; confusion; cool, pale skin; difficulty in thinking; dizziness or lightheadedness; drowsiness; excessive hunger; fast heartbeat; headache; nausea; nervousness; nightmares; restless sleep; shakiness; slurred speech; and tingling in the hands, feet, lips, or tongue

Less common or rare

Allergic reaction, including fast pulse, shortness of breath, skin rash or itching over the entire body, sweating, and wheezing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common or rare

Bloating or swelling of face, hands, lower legs, and/or feet

depression of skin at injection site

injection site pain

local allergy, including itching, redness, or swelling at injection site

thickening of skin at injection site

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Lantus side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

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More Lantus resources

Lantus Side Effects (in more detail)
Lantus Use in Pregnancy & Breastfeeding
Lantus Drug Interactions
Lantus Support Group
7 Reviews for Lantus - Add your own review/rating

Lantus Prescribing Information (FDA)

Lantus Monograph (AHFS DI)

Lantus Cartridge Systems MedFacts Consumer Leaflet (Wolters Kluwer)

Lantus Consumer Overview

Compare Lantus with other medications

Diabetes, Type 1
Diabetes, Type 2

Lantus SoloStar

Generic Name: insulin glargine, recombinant (Subcutaneous route)

IN-su-lin GLAR-jeen, ree-KOM-bi-nant

Commonly used brand name(s)

In the U.S.

Lantus

Lantus SoloStar

Available Dosage Forms:

Solution

Therapeutic Class: Antidiabetic

Pharmacologic Class: Insulin, Long Acting

Uses For Lantus SoloStar

This medicine is available only with your doctor's prescription.

Before Using Lantus SoloStar

Allergies

Pediatric

Geriatric

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Proper Use of insulin glargine, recombinant

This section provides information on the proper use of a number of products that contain insulin glargine, recombinant. It may not be specific to Lantus SoloStar. Please read with care.

Dosing

Each package of insulin glargine contains a patient information sheet. Read this sheet carefully and make sure you understand:

How to prepare the medicine.

How to inject the medicine.

How to dispose of syringes, needles, and injection devices.

It is best to use a different place on the body for each injection (e.g., abdomen, thigh, or upper arm). If you have questions about this, contact a member of your health care team.

Since insulin glargine lowers the blood glucose over 24 hours, it should be taken once daily at bedtime

For injection dosage form:
- For type 2 diabetes mellitus:
  - Adults, teenagers, and children 6 years of age or older—The dose is based on your blood sugar and must be determined by your doctor.
  - Children up to 6 years of age—Use and dose must be determined by your doctor.

Storage

Store in the refrigerator. Do not freeze.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

After a cartridge has been inserted into a pen, store the cartridge and pen at room temperature, not in the refrigerator.

Precautions While Using Lantus SoloStar

Your doctor will want to check your progress at regular visits, especially during the first few weeks you take this medicine.

It is very important to follow carefully any instructions from your health care team about:

Alcohol—Drinking alcohol may cause severe low blood sugar. Discuss this with your health care team.

Other medicines—Do not take other medicines during the time you are taking insulin glargine unless they have been discussed with your doctor. This especially includes nonprescription medicines such as aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems.

Counseling—Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, patients with diabetes may need special counseling about diabetes medicine dosing changes that might occur because of lifestyle changes, such as changes in exercise and diet. Furthermore, counseling on contraception and pregnancy is needed because of the problems that can occur in patients with diabetes during pregnancy.

Travel—Keep a recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times.

In case of emergency—There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to:

Wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says that you have diabetes and a list of all of your medicines.

Keep an extra supply of insulin glargine and syringes with needles or injection devices on hand in case high blood sugar occurs.

Keep some kind of quick-acting sugar handy to treat low blood sugar.

Have a glucagon kit and a syringe and needle available in case severe low blood sugar occurs. Check and replace any expired kits regularly.

If symptoms of high blood sugar occur, check your blood sugar level and then call your doctor for instructions.

Lantus SoloStar Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Convulsions (seizures)

unconsciousness

Check with your doctor as soon as possible if any of the following side effects occur:

More common

Low blood sugar, including anxious feeling; behavior change similar to being drunk; blurred vision; cold sweats; confusion; cool, pale skin; difficulty in thinking; dizziness or lightheadedness; drowsiness; excessive hunger; fast heartbeat; headache; nausea; nervousness; nightmares; restless sleep; shakiness; slurred speech; and tingling in the hands, feet, lips, or tongue

Less common or rare

Allergic reaction, including fast pulse, shortness of breath, skin rash or itching over the entire body, sweating, and wheezing

Less common or rare

Bloating or swelling of face, hands, lower legs, and/or feet

depression of skin at injection site

injection site pain

local allergy, including itching, redness, or swelling at injection site

thickening of skin at injection site

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Lantus SoloStar side effects (in more detail)

More Lantus SoloStar resources

Lantus SoloStar Side Effects (in more detail)
Lantus SoloStar Use in Pregnancy & Breastfeeding
Lantus SoloStar Drug Interactions
Lantus SoloStar Support Group
5 Reviews for Lantus SoloStar - Add your own review/rating

Compare Lantus SoloStar with other medications

Diabetes, Type 1
Diabetes, Type 2

lansoprazole

lan-SOE-pra-zole

Commonly used brand name(s)

In the U.S.

Prevacid

Prevacid SoluTab

Available Dosage Forms:

Tablet Disintegrating, Delayed Release

Capsule, Delayed Release

Packet

Therapeutic Class: Gastric Acid Secretion Inhibitor

Pharmacologic Class: Proton Pump Inhibitor

Uses For lansoprazole

Lansoprazole is used to treat certain conditions where there is too much acid in the stomach. It is used to treat duodenal and gastric ulcers, erosive esophagitis, and gastroesophageal reflux disease (GERD). GERD is a condition where the acid in the stomach washes back up into the esophagus. Sometimes lansoprazole is used in combination with antibiotics (e.g., amoxicillin, clarithromycin) to treat ulcers associated with an infection caused by H. pylori bacteria.

Lansoprazole is also used to treat Zollinger-Ellison syndrome (ZES), which is a condition where the stomach produces too much acid.

Lansoprazole is a proton pump inhibitor (PPI). It works by decreasing the amount of acid produced by the stomach.

lansoprazole is available both over-the-counter (OTC) and with your doctor's prescription.

Before Using lansoprazole

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For lansoprazole, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to lansoprazole or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of lansoprazole to treat GERD and erosive esophagitis in children 1 to 17 years of age. Safety and efficacy have not been established for children younger than 1 year of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of lansoprazole in the elderly.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking lansoprazole, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using lansoprazole with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Rilpivirine

Using lansoprazole with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Atazanavir

Citalopram

Dasatinib

Delavirdine

Erlotinib

Mycophenolate Mofetil

Nelfinavir

Nilotinib

Using lansoprazole with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acenocoumarol

Aluminum Carbonate, Basic

Aluminum Hydroxide

Aluminum Phosphate

Calcium Carbonate

Cranberry

Dicumarol

Dihydroxyaluminum Aminoacetate

Dihydroxyaluminum Sodium Carbonate

Magaldrate

Magnesium Carbonate

Magnesium Hydroxide

Magnesium Oxide

Magnesium Trisilicate

Phenprocoumon

Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Proper Use of lansoprazole

Take lansoprazole only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If you are using lansoprazole without a prescription, follow the instructions on the medicine label.

Take lansoprazole before a meal and for the full time of treatment, even if you begin to feel better after a few days.

If you are taking lansoprazole to treat an ulcer that is associated with an H. pylori infection, take it together with the antibiotics (e.g., amoxicillin, clarithromycin) at the same time of day.

To use the capsule:

Swallow the capsule whole. Do not break, crush, or chew it.

If the capsule cannot be swallowed, open it and sprinkle the contents on one tablespoonful of applesauce, Ensure® pudding, cottage cheese, yogurt, or strained pears. Swallow the mixture right away. Do not chew or crush the granules.

The contents of the capsule can also be mixed with 2 ounces (1/4 cup or 60 mL) of apple juice, orange juice, or tomato juice. After mixing, drink and swallow the mixture right away. Do not chew or crush the granules. Refill the cup 2 more times with juice and drink the liquid to make sure all of the medicine is taken.

To use the capsule with a nasogastric (NG) tube:

Open the capsule and mix the contents with 40 mL of apple juice. Do not use any other liquids.

Inject or pour the mixture into the nasogastric tube.

Flush the tube with more apple juice to rinse all of the medicine from the tube into the stomach.

To use the orally disintegrating tablet:

Make sure your hands are dry before you handle the tablet.

Do not crush, chew, break, or cut the tablet.

Place the tablet on the tongue, with or without water, and allow it to dissolve into particles. Swallow the particles right away.

To use the orally disintegrating tablet with an oral syringe:

Make sure your hands are dry before you handle the tablet.

Do not crush, break, or cut the tablet.

For the 15 mg tablet: Place it in the oral syringe and add 4 mL of water.

For the 30 mg tablet: Place it in the oral syringe and add 10 mL of water.

Shake the syringe gently until the tablet dissolves and is mixed well.

Give the mixture within 15 minutes.

Refill the syringe with 2 mL (15 mg tablet) or 5 mL (30 mg tablet) of water and shake it gently. Give the mixture to make sure all of the medicine is taken.

To use the orally disintegrating tablet with a nasogastric (NG) tube:

Make sure your hands are dry before you handle the tablet.

Do not crush, break, or cut the tablet.

For the 15 mg tablet: Place it in the syringe and add 4 mL of water.

For the 30 mg tablet: Place it in the syringe and add 10 mL of water.

Shake the syringe gently until the tablet dissolves and is mixed well.

Inject or pour the mixture into the nasogastric tube within 15 minutes.

Refill the syringe with 5 mL of water and shake it gently. Flush the tube with the water to rinse all of the medicine from the tube into the stomach.

Dosing

The dose of lansoprazole will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of lansoprazole. If your dose is different, do not change it unless your doctor tells you to do so.

For oral dosage forms (capsules or orally disintegrating tablets):
- To treat duodenal ulcers:
  - Adults—15 milligrams (mg) once a day before a meal. Your doctor may adjust your dose if needed.
  - Children—Use and dose must be determined by your doctor.
- To treat duodenal ulcers with H. pylori infection:
  - Adults—30 milligrams (mg) before meals 2 or 3 times a day. The dose is usually taken together with amoxicillin or clarithromycin plus amoxicillin. Your doctor may adjust your dose if needed.
  - Children—Use and dose must be determined by your doctor.
- To treat erosive esophagitis:
  - Adults—15 to 30 milligrams (mg) once a day before a meal. Your doctor may adjust your dose if needed.
  - Teenagers and children 12 years of age—30 mg once a day before a meal. Your doctor may adjust your dose if needed.
  - Children 1 to 11 years of age and weighing over 30 kg—30 mg once a day before a meal. Your doctor may adjust your dose if needed.
  - Children 1 to 11 years of age and weighing 30 kg or less—15 mg once a day before a meal. Your doctor may adjust your dose if needed.
  - Children younger than 1 year of age—Use and dose must be determined by your doctor.
- To treat gastric ulcers:
  - Adults—15 to 30 milligrams (mg) once a day before a meal. Your doctor may adjust your dose if needed.
  - Children—Use and dose must be determined by your doctor.
- To treat gastroesophageal reflux disease (GERD):
  - Adults, teenagers, and children 12 years of age—15 milligrams (mg) once a day before a meal. Your doctor may adjust your dose if needed.
  - Children 1 to 11 years of age and weighing over 30 kg—30 mg once a day before a meal. Your doctor may adjust your dose if needed.
  - Children 1 to 11 years of age and weighing 30 kg or less—15 mg once a day before a meal. Your doctor may adjust your dose if needed.
  - Children younger than 1 year of age—Use and dose must be determined by your doctor.
- To treat Zollinger-Ellison syndrome (ZES):
  - Adults—60 milligrams (mg) once a day before a meal. Your doctor may adjust your dose if needed.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of lansoprazole, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using lansoprazole

It is important that your doctor check the progress of you or your child at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects. If your or your child's condition does not improve, or if it becomes worse, discuss this with your doctor.

Lansoprazole may increase your risk of having fractures of the hip, wrist, and spine. This is more likely if you have osteoporosis, if you are 50 years of age and older, if you receive high doses of lansoprazole, or use it for one year or more.

lansoprazole may cause hypomagnesemia (low magnesium in the blood). This is more likely to occur if you are taking lansoprazole for more than one year, or if you are taking lansoprazole together with digoxin (Lanoxin®) or certain diuretics or "water pills". Stop using lansoprazole and check with your doctor right away if you have convulsions (seizures); fast, racing, or uneven heartbeat; muscle spasms (tetany); tremors; or unusual tiredness or weakness.

Do not stop taking lansoprazole without first checking with your doctor, or unless told to do so by your doctor.

Before you have any medical tests, tell the medical doctor in charge that you or your child are taking lansoprazole. The results of some tests may be affected by lansoprazole.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

lansoprazole Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Diarrhea

skin rash or itching

Less common

Abdominal or stomach pain

increased or decreased appetite

joint pain

nausea

vomiting

Rare

Anxiety

cold or flu-like symptoms

constipation

increased cough

mental depression

muscle pain

rectal bleeding

unusual bleeding or bruising

Incidence not known

Abdominal or stomach tenderness

back, leg, or stomach pains

bleeding gums

blistering, peeling, or loosening of the skin

bloating

bloody, black, or tarry stools

change in mental status

chest pain

chills

clay colored stools

constipation

cough or hoarseness

dark or bloody urine

difficulty with swallowing

drowsiness

fast heartbeat

fever

general body swelling

high fever

hives

indigestion

loss of appetite

lower back or side pain

mood or mental changes

muscle spasms (tetany) or twitching seizures

nosebleeds

painful or difficult urination

pains in the stomach, side, or abdomen, possibly radiating to the back

pale skin

pinpoint red spots on the skin

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

red, irritated eyes

red skin lesions, often with a purple center

seizures

shortness of breath

sore throat

sores, ulcers, or white spots on the lips or in the mouth

swelling of the feet or lower legs

swollen or painful glands

tightness in the chest

trembling

unusual tiredness or weakness

wheezing

yellowing of the eyes or skin

More common

Dizziness

headache

Less common

Bleeding, blistering, burning, coldness, or discoloration of the skin

mild nausea

Rare

Acid or sour stomach

bad, unusual or unpleasant (after) taste

belching

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

change in taste

feeling faint, dizzy, or lightheaded

feeling of heat or warmth

flushing or redness of the skin, especially on the face and neck

heartburn

indigestion

mild diarrhea

mild headache

mild vomiting

stomach discomfort, upset, or pain

sweating

Incidence not known

Decrease in passing urine (dribbling)

decrease in the frequency of urination

decrease in urine volume

difficulty with speaking

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: lansoprazole side effects (in more detail)

More lansoprazole resources

Lansoprazole Side Effects (in more detail)
Lansoprazole Use in Pregnancy & Breastfeeding
Drug Images
Lansoprazole Drug Interactions
Lansoprazole Support Group
27 Reviews for Lansoprazole - Add your own review/rating

Lansoprazole Professional Patient Advice (Wolters Kluwer)

Lansoprazole Prescribing Information (FDA)

Lansoprazole MedFacts Consumer Leaflet (Wolters Kluwer)

Lansoprazole Monograph (AHFS DI)

Prevacid Consumer Overview

Prevacid Delayed-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)

Prevacid Prescribing Information (FDA)

Prevacid SoluTab Orally Disintegrating Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Compare lansoprazole with other medications

Aspiration Pneumonia
Barrett's Esophagus
Duodenal Ulcer
Duodenal Ulcer Prophylaxis
Erosive Esophagitis
GERD
Helicobacter Pylori Infection
Multiple Endocrine Adenomas
NSAID-Induced Gastric Ulcer
NSAID-Induced Ulcer Prophylaxis
Stomach Ulcer
Systemic Mastocytosis
Zollinger-Ellison Syndrome

Lansoprazole

Pronunciation: lan-SOE-pra-zole
Generic Name: Lansoprazole
Brand Name: Prevacid I.V.

Lansoprazole is used for:

Short-term treatment of irritation of the esophagus when medicine cannot be taken by mouth. It may also be used for other conditions as determined by your doctor.

Lansoprazole is a proton pump inhibitor. It works by decreasing the amount of acid produced in the stomach.

Do NOT use Lansoprazole if:

you are allergic to any ingredient in Lansoprazole

you are taking an HIV protease inhibitor (eg, atazanavir)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Lansoprazole:

Some medical conditions may interact with Lansoprazole. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have liver problems or stomach or bowel cancer

if you have osteoporosis (weak bones), a family history of osteoporosis, or other risk factors of osteoporosis (eg, smoking, poor nutrition)

Some MEDICINES MAY INTERACT with Lansoprazole. Tell your health care provider if you are taking any other medicines, especially any of the following:

Clarithromycin or voriconazole because it may increase the risk of Lansoprazole's side effects

Anticoagulants (eg, warfarin), digoxin, or tacrolimus because the risk of their side effects may be increased by Lansoprazole

Azole antifungals (eg, ketoconazole), clopidogrel, HIV protease inhibitors (eg, atazanavir), iron, or theophylline because their effectiveness may be decreased by Lansoprazole

This may not be a complete list of all interactions that may occur. Ask your health care provider if Lansoprazole may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Lansoprazole:

Use Lansoprazole as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Lansoprazole is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Lansoprazole at home, a health care provider will teach you how to use it. Be sure you understand how to use Lansoprazole. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.

Do not use Lansoprazole if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.

If you are also taking an imidazole antifungal (eg, ketoconazole), take it at least 2 hours before using Lansoprazole.

Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.

Lansoprazole should only be used for a short time (up to 7 days) until you are able to take medicine by mouth. Discuss any questions or concerns with your doctor.

If you miss a dose of Lansoprazole, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Lansoprazole.

Important safety information:

Lansoprazole may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Lansoprazole with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Contact your doctor if you have any symptoms of a bleeding ulcer, such as black, tarry stools or vomit that looks like coffee grounds; or if you experience throat pain, chest pain, severe stomach pain, or trouble swallowing.

Lansoprazole may increase the risk of hip, wrist, and spine fractures. The risk may be greater if you use Lansoprazole in high doses, for long periods of time, or if you are over 50 years old. Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor. Contact your doctor if you have any questions about this information.

Check with your doctor to see whether you should take a calcium and vitamin D supplement while you use Lansoprazole.

Lansoprazole may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using Lansoprazole.

Lansoprazole should be used with caution in Asian patients; the risk of side effects may be increased in these patients.

Use Lansoprazole with caution in the ELDERLY; they may be more sensitive to its effects, especially hip, wrist, and spine fractures.

Lansoprazole should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Lansoprazole while you are pregnant. It is not known if Lansoprazole is found in breast milk. Do not breast-feed while taking Lansoprazole.

Possible side effects of Lansoprazole:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; headache; nausea; pain, swelling, or redness at the injection site; stomach pain.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); bone pain; chest pain; fast or irregular heartbeat; fever, chills, or sore throat; red, swollen, blistered, or peeling skin; seizures; unusual bruising or bleeding; unusual tiredness; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Lansoprazole side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Lansoprazole:

Lansoprazole is usually handled and stored by a health care provider. If you are using Lansoprazole at home, store Lansoprazole as directed by your pharmacist or health care provider. Keep Lansoprazole out of the reach of children and away from pets.

General information:

If you have any questions about Lansoprazole, please talk with your doctor, pharmacist, or other health care provider.

Lansoprazole is to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Lansoprazole. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Lansoprazole resources

Lansoprazole Side Effects (in more detail)
Lansoprazole Use in Pregnancy & Breastfeeding
Drug Images
Lansoprazole Drug Interactions
Lansoprazole Support Group
27 Reviews for Lansoprazole - Add your own review/rating

Lansoprazole Prescribing Information (FDA)

Lansoprazole Professional Patient Advice (Wolters Kluwer)

Lansoprazole Monograph (AHFS DI)

lansoprazole Advanced Consumer (Micromedex) - Includes Dosage Information

Prevacid Prescribing Information (FDA)

Prevacid Consumer Overview

Compare Lansoprazole with other medications

Aspiration Pneumonia
Barrett's Esophagus
Duodenal Ulcer
Duodenal Ulcer Prophylaxis
Erosive Esophagitis
GERD
Helicobacter Pylori Infection
Multiple Endocrine Adenomas
NSAID-Induced Gastric Ulcer
NSAID-Induced Ulcer Prophylaxis
Stomach Ulcer
Systemic Mastocytosis
Zollinger-Ellison Syndrome

Lanacane Maximum Strength

Generic Name: benzocaine topical (BENZ oh kane TOP ik al)

Brand Names: Americaine, Americaine Hemorrhoidal, Anacaine, Anbesol Gel, Anbesol Liquid, Babee Teething Lotion, Benzo-O-Stetic, Boil Ease Pain Relieving, Cepacol Extra Strength, Cepacol Fizzlers, Dent-O-Kain, Dermoplast, Detane, Hurricaine, Lanacane, Maintain, Medicone Maximum Strength, Num-Zit, Numzident, Orabase, Orabase Gel-B, Orajel, Orajel Denture, Oral Pain Relief, OraMagic Plus, Outgro Pain Relief, Retre-Gel, Rid-A-Pain, Skeeter Stik, Solarcaine Aerosol, Sting-Kill, Topex, Trocaine, Vagisil Feminine Cream, zilactin-B

What is Lanacane Maximum Strength (benzocaine topical)?

Benzocaine is a local anesthetic (numbing medication). It works by blocking nerve signals in your body.

Benzocaine topical is used to reduce pain or discomfort caused by minor skin irritations, sore throat, sunburn, teething pain, vaginal or rectal irritation, ingrown toenails, hemorrhoids, and many other sources of minor pain on a surface of the body. Benzocaine is also used to numb the skin or surfaces inside the mouth, nose, throat, vagina, or rectum to lessen the pain of inserting a medical instrument such as a tube or speculum.

There are many brands and forms of benzocaine topical available and not all brands are listed on this leaflet.

Benzocaine topical may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Lanacane Maximum Strength (benzocaine topical)?

There are many brands and forms of benzocaine topical available and not all brands are listed on this leaflet.

Benzocaine topical used in the mouth or throat may cause a life-threatening condition in which the amount of oxygen in your blood stream becomes dangerously low. This condition is called methemoglobinemia (met-HEEM-oh glo-bin-EE-mee-a) and it may occur after only one use of benzocaine or after several uses.

Signs and symptoms of methemoglobinemia may occur within minutes or up to 2 hours after using benzocaine topical in the mouth or throat. GET EMERGENCY MEDICAL HELP IF YOU HAVE ANY OF THESE SYMPTOMS: headache, tired feeling, confusion, fast heart rate, and feeling light-headed or short of breath, with a pale, blue, or gray appearance of your skin, lips, or fingernails.

Do not use benzocaine topical if you have ever had methemoglobinemia in the past. Do not use this medicine on a child younger than 2 years old without medical advice. An overdose of numbing medications can cause fatal side effects if too much of the medicine is absorbed through your skin and into your blood. This is more likely to occur when using a numbing medicine without the advice of a medical doctor (such as during a cosmetic procedure like laser hair removal). Overdose symptoms may include uneven heartbeats, seizure (convulsions), coma, slowed breathing, or respiratory failure (breathing stops).

Use the smallest amount of this medication needed to numb the skin or relieve pain. Do not use large amounts of benzocaine topical, or cover treated skin areas with a bandage or plastic wrap without medical advice. Be aware that many cosmetic procedures are performed without a medical doctor present.

Your body may absorb more of this medication if you use too much, if you apply it over large skin areas, or if you apply heat, bandages, or plastic wrap to treated skin areas. Skin that is cut or irritated may also absorb more topical medication than healthy skin.

Before using benzocaine topical, tell your doctor if you have any type of inherited enzyme deficiency, heart disease, a breathing disorder such as asthma, bronchitis, or emphysema, or if you smoke.

If you are treating a sore throat, call your doctor if the pain is severe or lasts longer than 2 days, especially if you also develop a fever, headache, skin rash, swelling, nausea, vomiting, cough, or breathing problems.

What should I discuss with my health care provider before using Lanacane Maximum Strength (benzocaine topical)?

Do not use benzocaine topical if you have ever had methemoglobinemia in the past. An overdose of numbing medications can cause fatal side effects if too much of the medicine is absorbed through your skin and into your blood. This is more likely to occur when using a numbing medicine without the advice of a medical doctor (such as during a cosmetic procedure like laser hair removal). Overdose symptoms may include uneven heartbeats, seizure (convulsions), coma, slowed breathing, or respiratory failure (breathing stops).

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:

asthma, bronchitis, emphysema, or other breathing disorder;

heart disease;

a personal or family history of methemoglobinemia, or any genetic (inherited) enzyme deficiency; or

if you smoke.

FDA pregnancy category C. It is not known whether benzocaine topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.. It is not known whether benzocaine topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not use this medicine on a child younger than 2 years old without medical advice.

How should I use Lanacane Maximum Strength (benzocaine topical)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Use the smallest amount of medicine needed to numb the skin or relieve pain. Do not use large amounts of benzocaine topical, or cover treated skin areas with a bandage or plastic wrap without medical advice. Be aware that many cosmetic procedures are performed without a medical doctor present.

This medication comes with instructions for safe and effective application. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

To treat minor skin conditions, apply a thin layer of benzocaine topical to the affected area up to 4 times per day. If using the spray, hold the container 6 to 12 inches away from the skin. Do not spray this medication onto your face. Spray it instead on your hands and then rub it onto the face, avoiding contact with your eyes.

To treat hemorrhoids, clean the area with soap and water before applying benzocaine topical. Apply the medication up to 6 times per day. If you are using the rectal suppository, try to empty your bowel and bladder before inserting the suppository. Remove the outer wrapper from the suppository before inserting it. Avoid handling the suppository too long or it will melt in your hands.

Do not use benzocaine topical to treat large skin areas or deep puncture wounds. Avoid using the medicine on skin that is raw or blistered, such as a severe burn or abrasion.

Call your doctor if your symptoms do not improve or if they get worse within the first 7 days of using benzocaine topical. Also call your doctor if your symptoms had cleared up but then came back.

Store at room temperature away from moisture and heat. Do not freeze.

What happens if I miss a dose?

Since benzocaine topical is used as needed, you may not be on a dosing schedule. If you are using the medication regularly, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of benzocaine topical applied to the skin can cause life-threatening side effects such as uneven heartbeats, seizure (convulsions), coma, slowed breathing, or respiratory failure (breathing stops).

What should I avoid while taking Lanacane Maximum Strength (benzocaine topical)?

Avoid eating within 1 hour after using benzocaine topical on your gums or inside your mouth.

Benzocaine topical is for use only on the surface of your body, or just inside the mouth, vagina, or rectum. Avoid getting this medication in your eyes. Avoid swallowing the gel, liquid, or ointment while applying it to your gums or the inside of your mouth. The throat spray or oral lozenge may be swallowed gradually during use.

Do not apply other medications to the same affected areas you treat with benzocaine topical, unless your doctor has told you otherwise.

Lanacane Maximum Strength (benzocaine topical) side effects

Signs and symptoms may occur within minutes or up to 2 hours after using benzocaine topical in the mouth or throat. GET EMERGENCY MEDICAL HELP IF YOU HAVE:

headache, tired feeling, confusion;

fast heart rate;

feeling light-headed or short of breath; and

pale, blue, or gray appearance of your skin, lips, or fingernails.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using benzocaine topical and call your doctor at once if you have any of these other serious side effects:

headache, weakness, dizziness, breathing problems, fast heart rate, and gray or bluish colored skin (rare but serious side effects of benzocaine);

severe burning, stinging, or sensitivity where the medicine is applied;

swelling, warmth, or redness; or

oozing, blistering, or any signs of infection.

Less serious side effects may include:

mild stinging, burning, or itching where the medicine is applied;

skin tenderness or redness; or

dry white flakes where the medicine was applied.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Lanacane Maximum Strength (benzocaine topical)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied benzocaine topical. But many drugs can interact with each other. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Lanacane Maximum Strength resources

Lanacane Maximum Strength Side Effects (in more detail)
Lanacane Maximum Strength Use in Pregnancy & Breastfeeding
Lanacane Maximum Strength Support Group
1 Review for Lanacane Maximum Strength - Add your own review/rating

Americaine Ointment MedFacts Consumer Leaflet (Wolters Kluwer)

Anacaine Advanced Consumer (Micromedex) - Includes Dosage Information

Anbesol Extra Strength Advanced Consumer (Micromedex) - Includes Dosage Information

Benz-O-Sthetic Gel MedFacts Consumer Leaflet (Wolters Kluwer)

Lanacane Aerosol Spray MedFacts Consumer Leaflet (Wolters Kluwer)

OraMagic Plus Suspension MedFacts Consumer Leaflet (Wolters Kluwer)

Rid-A-Pain Topical Advanced Consumer (Micromedex) - Includes Dosage Information

Compare Lanacane Maximum Strength with other medications

Pruritus
Sunburn

Where can I get more information?

Your pharmacist can provide more information about benzocaine topical.

See also: Lanacane Maximum Strength side effects (in more detail)

Lexuss 210 Liquid

codeine phosphate and chlorpheniramine maleate

Dosage Form: liquid
Lexuss 210 Liquid

CV

Drug Facts

Active Ingredients

Each 5 mL (1 teaspoonful) of vanilla cream flavored liquid for oral administration contains:

: 10 mg Codeine Phosphate
: 2 mg Chlorpheniramine Maleate

Purpose

Cough Suppressant

Antihistamine

Codeine is one of the naturally occurring phenanthrene alkaloids of opium derived from the opium poppy, it is classified pharmacologically as a narcotic analgesic. Codeine phosphate may be chemically designated as 7.8-Didehydro-4, 5α-epoxy-3-methoxy-17-methylmorphinan-6-α-ol phosphate (1:1)(salt)hemihydrate. The phosphate salt of codeine occurs as white, needle-shaped crystals or white crystalline powder. Codeine phosphate is freely soluble in water and slightly soluble in alcohol and has the following chemical structure:

C18H21NO3 • H3PO4 • ½H2O M.W. 406.37

Chlorpheniramine Maleate is an antihistamine having the chemical name: 2-Pyridinepropanamine, γ-(4-chlorophenyl)-N,N-dimethyl-, (Z)-2-butenedioate (1:1), and has the following chemical structure:

C16H19ClN2 • C4H4O4 M.W. 390.86

Lexuss 210 Liquid - Clinical Pharmacology

Codeine

Narcotic analgesics, including codeine, exert their primary effects on the central nervous system and gastrointestinal tract. The analgesic effects of codeine are due to its central action; however, the precise sites of action have not been determined, and the mechanisms involved appear to be quite complex. Codeine resembles morphine both structurally and pharmacologically, but its actions at the doses of codeine used therapeutically are milder, with less sedation, respiratory depression, and gastrointestinal, urinary, and pupilary effects. Codeine produces an increase in biliary tract pressure, but less than morphine or meperidine. Codeine is less constipating than morphine. Codeine has good antitussive activity, although less than that of morphine at equal doses. It is used in preference to morphine, because side effects are infrequent at the usual antitussive dose of codeine. Codeine in oral therapeutic dosage does not usually exert major effects on the cardiovascular system. Narcotic analgesics may cause nausea and vomiting by stimulating the chemoreceptor trigger zone (CTZ); however, they also depress the vomiting center, so that subsequent doses are unlikely to produce vomiting. Nausea is minimal after usual oral doses of codeine. Narcotic analgesics cause histamine release, which appears to be responsible for wheals or urticaria sometimes seen at the site of injection on parenteral administration. Histamine release may also produce dilation of cutaneous blood vessels, with resultant flushing of the face and neck, pruritus, and sweating.

Codeine and its salts are well absorbed following both oral and parenteral administration. Codeine is about 2/3 as effective orally as parenterally. Codeine is metabolized primarily in the liver by enzymes of the endoplasmic reticulum, where it undergoes 0-demethylation, N-demethylation, and partial conjugation with glucuronic acid. The drug is excreted primarily in the urine, largely as inactive metabolites and small amounts of free and conjugated morphine. Negligible amounts of codeine and its metabolites are found in the feces. Following oral or subcutaneous administration of codeine, the onset of analgesia occurs within 15 to 30 minutes and lasts for four to six hours. The cough-depressing action, in animal studies, was observed to occur 15 minutes after oral administration of codeine, peak action at 45 to 60 minutes after ingestion. The duration of action, which is dose-dependent, usually did not exceed 3 hours.

Chlorpheniramine

Chlorpheniramine Maleate is an alkylamine-type antihistamine that possesses anticholinergic and sedative effects. Antihistamines competitively antagonize histamine at the H1 receptor site. Thus, activation of H1 receptors by released histamine which results in increased vascular permeability, increased mucus production, pruritis and sneezing is prevented.

INDICATIONS

Temporarily relieves runny nose and alleviates sneezing, itching of the nose or throat, and itchy watery eyes due to hay fever or allergic rhinitis; for the temporary control of cough due to minor throat and bronchial irritation associated with the common cold or inhaled irritants; calms the cough control center and relieves coughing.

Contraindications

Codeine is contraindicated in patients with a known hypersensitivity to the drug. Antihistamines and codeine are both contraindicated for use in the treatment of lower respiratory tract symptoms, including asthma. Antihistamines and anticholinergics are contraindicated in patients with narrow-angle glaucoma, urinary retention, peptic ulcer and during an asthma attack. Contraindicated in breast-feeding mothers.

Warnings

Do not exceed recommended dosage. If nervousness, dizziness, or sleeplessness occur, discontinue use and consult a doctor. When using this product, Lexuss 210 Liquid may cause marked drowsiness.

A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache, consult a doctor.

Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus) unless directed by a physician.

Adults and children who have a chronic pulmonary disease or shortness of breath, or children who are taking other drugs, should not take this product unless directed by a physician.

Dosage of codeine SHOULD NOT BE INCREASED if cough fails to respond; an unresponsive cough should be reevaluated in 5 days or sooner for possible underlying pathology, such as foreign body or lower respiratory tract disease.

Codeine may cause or aggravate constipation.

Respiratory depression leading to arrest, coma, and death has occurred with the use of codeine antitussive in young children, particularly in the under-one-year infants whose ability to deactivate the drug is not fully developed.

Administration of codeine may be accomplished by histamine release and should be used with caution in atopic children.

Head Injury and Increased Intracranial Pressure

The respiratory depressant effects of narcotic analgesics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, intracranial lesions, or a reexisting increase in intracranial pressure. Narcotics may produce adverse reactions which may obscure the clinical course of patients with head injuries.

Asthma and Other Respiratory Conditions

Narcotic analgesics or cough suppressants, including codeine, should not be used in asthmatic patients. Nor should they be used in acute febrile illness associated with productive cough or in chronic respiratory disease where interference with ability to clear the tracheobronchial tree of secretions would have a deleterious effect on the patient's respiratory function.

Hypotensive Effect

Codeine may produce orthostatic hypotension in ambulatory patients.

Antihistamines may cause excitability especially in children. Do not take this product, unless directed by a physician, if you have a breathing problem such as emphysema or chronic bronchitis, or if you have glaucoma or difficulty in urination due to enlargement of the prostate gland. May cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor. Use caution when driving a motor vehicle or operating machinery.

Precautions

General

Before prescribing medication to suppress or modify cough, it is important that the underlying cause of cough is identified, that modification of cough does not increase the risk of clinical or physiological complications, and that appropriate therapy for the primary disease is instituted.

Narcotic analgesics, including codeine, should be administered with caution and the initial dose reduced in patients with acute abdominal conditions, convulsive disorders, significant hepatic or renal impairment, fever, hypothyroidism, Addison's disease, ulcerative colitis, prostatic hypertrophy, in patients with recent gastrointestinal or urinary tract surgery, and in the very young or elderly or debilitated patients.

Ultra-rapid Metabolizers of Codeine

Some individuals may be ultra-rapid metabolizers due to a specific CYP2D6*2x2 genotype. These individuals convert codeine into its active metabolite, morphine, more rapidly and completely than other people. This rapid conversion results in higher than expected serum morphine levels. Even at labeled dosage regiments, individuals who are ultra-rapid metabolizers may experience overdose symptoms such as extreme sleepiness, confusion or shallow breathing.

The prevalence of this CYP2D6 phenotype varies widely and has been estimated at 0.5 to 1% in Chinese and Japanese, 0.5 to 1% in Hispanics, 1-10% in Caucasians, 3% in African Americans, and 16-28% in North Africans, Ethiopians and Arabs. Data is not available for other ethnic groups.

When physicians prescribe codeine-containing drugs, they should choose the lowest effective dose for the shortest period of time and should inform their patients about these risks and the signs of morphine overdose.

Drug/Laboratory Test Interactions

In patients receiving MAO inhibitors, an initial small test dose is advisable to allow observation of any excessive narcotic effects or MAOI interaction.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No data are available on the long-term potential for carcinogenesis, mutagenesis, or impairment of fertility in animals or humans.

Pregnancy

Pregnancy Category C

A study in rats and rabbits reported no teratogenic effect of codeine administered during the period of organogenesis in doses ranging from 5 to 120 mg/kg. In the rat, doses at the 120-mg/kg level, in the toxic range for the adult animal were associated with an increase in embryo resorption at the time of implantation. In another study a single 100-mg/kg dose of codeine administered to pregnant mice reportedly resulted in delayed ossification in the offspring. There are no studies in humans, and the significance of these findings to humans, if any, is not known. Do not use during third trimester.

Labor and Delivery

Narcotic analgesics cross the placental barrier. The closer to delivery and the larger the dose used, the greater the possibility of respiratory depression in the newborn. Narcotic analgesics should be avoided during labor if delivery of a premature infant is anticipated. If the mother has received narcotic analgesics during labor, newborn infants should be observed closely for signs of respiratory depression. Resuscitation may be required.

Nursing Mothers

Codeine is secreted into human milk. In women with normal codeine metabolism (normal CYP2D6 activity), the amount of codeine secreted into human milk is low and dose-dependent. Despite the common use of codeine products to manage postpartum pain, reports of adverse events in infants are rare. However, some women are ultra-rapid metabolizers of codeine. These women achieve higher-than-expected serum levels of codeine's active metabolite, morphine, leading to higher-than-expected levels of morphine in breast milk and potentially dangerously high serum morphine levels in their breastfed infants. Therefore, maternal use of codeine can potentially lead to serious adverse reactions, including death, in nursing infants.

The risk of infant exposure to codeine and morphine through breast milk should be weighed against the benefits of breastfeeding for both the mother and baby. Caution should be exercised when codeine is administered to a nursing woman. If a codeine containing product is selected, the lowest dose should be prescribed for the shortest period of time to achieve the desired clinical effect. Mothers using codeine should be informed about when to seek immediate medical care and how to identify the signs and symptoms of neonatal toxicity, such as drowsiness or sedation, difficulty breastfeeding, breathing difficulties, and decreased tone in their baby. Nursing mothers who are ultra-rapid metabolizers may also experience overdose symptoms such as extreme sleepiness, confusion or shallow breathing. Prescribers should closely monitor mother-infant pairs and notify treating pediatricians about the use of codeine during breastfeeding.

Information for Patients

Codeine may cause marked drowsiness or may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. Ambulatory patients should be told to avoid engaging in such activities until it is known that they do not become drowsy or dizzy from codeine therapy.

The concomitant use of alcohol or other central nervous system depressants, including narcotic analgesics, sedatives, hypnotics, and tranquilizers, may have an additive effect and should be avoided or their dosage reduced.

Patients should be advised to report any involuntary muscle movements. Avoid prolonged exposure to the sun. Codeine, like other narcotic analgesics, may produce orthostatic hypotension in some ambulatory patients. Patients should be cautioned accordingly. Caution patients that some people have a variation in a liver enzyme and change codeine into morphine more rapidly and completely than other people. These people are ultra-rapid metabolizers and are more likely to have higher-than-normal levels of morphine in their blood after taking codeine which can result in overdose symptoms such as extreme sleepiness, confusion, or shallow breathing. In most cases, it is unknown if someone is an ultra-rapid codeine metabolizer. Nursing mothers taking codeine can also have higher morphine levels in their breast milk if they are ultra-rapid metabolizers. These higher levels of morphine in breast milk may lead to life-threatening or fatal side effects in nursing babies. Instruct nursing mothers to watch for signs of morphine toxicity in their infants including increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties, or limpness. Instruct nursing mothers to talk to the baby's doctor immediately if they notice these signs and, if they cannot reach the doctor right away, to take the baby to an emergency room or call 911 (or local emergency services).

Caution patient using Chlorpheniramine that each product has specific dosing instructions and to read package label before using and not to exceed dose or frequency of administration instructions. Advise patient to take each dose without regard to meals, but to take with food if stomach upset occurs. Advise patient or caregiver using oral syrup to measure and administer prescribed dose using dosing syringe, dosing spoon, or dosing cup. Advise patient that if a dose is missed, to take it as soon as possible unless it is nearing time for the next scheduled dose. If it is nearing time for next scheduled dose, advise patient to skip the missed dose and take the next dose at the regularly scheduled time. Caution patient not to double the dose to catch up. Advise patient that if allergy symptoms are not controlled, not to increase the dose of medication or frequency of use but to inform health care provider. Caution patient that larger doses or more frequent dosing does not increase efficacy and may cause excessive drowsiness or other adverse reactions. Instruct patient to stop taking drug and immediately report any of these symptoms to health care provider: persistent dizziness; excessive drowsiness; severe dry mouth, nose, or throat; flushing; unexplained shortness of breath or difficulty breathing; unusual tiredness or weakness; sore throat, fever, or other signs of infection; bleeding or unusual bruising; fast or irregular heartbeat; excitability, confusion, or changes in thinking or behavior; chest tightness; difficulty with urination. Advise patient medication may cause drowsiness or dizziness and not to drive or perform other activities requiring mental alertness until tolerance is determined. Advise patient to take sips of water, suck on ice chips or sugarless hard candy, or chew sugarless gum if dry mouth occurs. Caution patient alcohol and other CNS depressants (e.g., sedatives) will have additional sedative effects if taken with Chlorpheniramine. Caution patient not to take any other OTC antihistamines while taking this medication unless advised by health care provider. Caution patient that medication may cause sensitivity to sunlight and to avoid excessive exposure to the sun or UV light (e.g., tanning booths) and to wear protective clothing and use sunscreens until tolerance is determined. If patient is to have allergy skin testing, advise patient not to take the medication for at least 4 days before the skin testing.

Use in the Elderly

Use with caution, usually starting at the low end of the dosage range because of the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant diseases or other drug therapy.

Adverse Reactions

Phenylephrine HCl

Codeine

Nervous System - CNS depression, particularly respiratory depression, and to a lesser extent circulatory depression; light-headedness, dizziness, sedation, euphoria, dysphoria, headache, transient hallucination, disorientation, visual disturbances, and convulsions.

Cardiovascular – Tachycardia, bradycardia, palpitation, faintness, syncope, orthostatic hypotension (common to narcotic analgesics).

Gastrointestinal – Nausea, vomiting, constipation, and biliary tract spasm. Patients with chronic ulcerative colitis may experience increased colonic motility; in patients with acute ulcerative colitis, toxic dilation has been reported.

Genitourinary – Oliguria, urinary retention, antidiuretic effect has been reported (common to narcotic analgesics).

Allergic – Infrequent pruritus, giant urticaria, angioneurotic edema, and laryngeal edema.

Other – Flushing of the face, sweating and pruritus (due to opiate-induced histamine release); weakness.

Drug Abuse and Dependence

Lexuss 210 Liquid is subject to Federal Controlled Substances Act (Schedule V).

Abuse

Codeine is known to be subject to abuse; however, the abuse potential of oral codeine appears to be quite low. Even parenteral codeine does not appear to offer the psychic effects sought by addicts to the same degree as heroin or morphine. However, codeine must be administered only under close supervision to patients with a history of drug abuse or dependence.

Dependence

Psychological dependence, physical dependence, and tolerance are known to occur with codeine.

Overdosage

Serious overdose with codeine is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, and sometimes bradycardia and hypotension. The triad of coma, pinpoint pupils, and respiratory depression is strongly suggestive of opiate poisoning. In severe overdosage, particularly by the intravenous route, apnea, circulatory collapse, cardiac arrest, and death may occur. It is difficult to determine what constitutes a standard toxic or lethal dose. However, the lethal oral dose of codeine in an adult is reported to be in the range of 0.5 to 1 gram. Infants and children are believed to be relatively more sensitive to opiates on a body-weight basis. Elderly patients are also comparatively intolerant to opiates. Treatment of overdosage with codeine is essentially symptomatic and supportive. Only in cases of extreme overdosage or individual sensitivity do vital signs including respiration, pulse, blood pressure, temperature, and EKG need to be monitored. Activated charcoal orally or by lavage may be given, or sodium or magnesium sulfate orally as a cathartic. Attention should be given to the reestablishment of adequate respiratory exchange through provision of a patient airway and institution of assisted or controlled ventilation. The narcotic antagonist, naloxone hydrochloride, may be administered when significant respiratory depression occurs with codeine; Severe hypotension usually responds to the administration of norepinephrine or Phenylephrine. EPINEPHRINE SHOULD NOT BE USED, since its use in a patient with partial adrenergic blockade may further lower the blood pressure. Limited experience with dialysis indicates that it is not helpful. Overdosage with Chlorpheniramine may cause hallucinations, convulsions, and death. Antihistamines may diminish mental alertness. In young children, they may produce paradoxical excitation.

DOSAGE AND ADMINISTRATION1

Adults and children 12 years of age and over: 1 to 2 teaspoonfuls (5-10 mL) every 4 to 6 hours. Not to exceed 8 teaspoonfuls in a 24 hour period.

Children 6 to under 12 years of age: 1/2 to 1 teaspoonful (2.5 - 5 mL) every 4 to 6 hours. Not to exceed 4 teaspoonfuls in a 24 hour period.

Also contains the following inactive ingredients (in alphabetical order): Citric Acid, Methyl Paraben, Potassium Citrate, Potassium Sorbate, Propyl Paraben, Propylene Glycol, Purified Water, Sorbitol Solution 70%, Sucralose, Vanilla Ice Cream Flavor

1: In mild cases or in particularly sensitive patients, less frequent or reduced doses may be appropriate and adequate. Shake liquid well before use.

How is Lexuss 210 Liquid Supplied

Lexuss 210 Liquid is a clear solution with a vanilla aroma which contains 10 mg Codeine Phosphate and 2 mg Chlorpheniramine Maleate, available in 16 fl oz (473 mL) bottles.

NDC 23359-016-16

WARNING

KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

Rx Only

Dispense in a tight, light-resistant container as defined in USP/NF with a child-resistant closure.

Store at controlled room temperature 15°-30°C (59°-86°F).

Manufactured for:

Centurion Labs, LLC

Birmingham, AL 35243

Manufactured by:

TG United Liquid, Inc.

Brooksville, FL 34604

Rev. 03/09

PRINCIPAL DISPLAY PANEL - 473 mL Label

NDC 23359-016-16

LEXUSS 210

Liquid

COUGH SUPPRESSANT

ANTIHISTAMINE

Sugar Free

EACH TEASPOONFUL (5 mL)

CONTAINS:

Codeine Phosphate 10 mg

Chlorpheniramine Maleate 2 mg

Vanilla Cream Flavor

Alcohol Content 0.1%

16 fl oz (473 mL)

Rx Only

LEXUSS 210
codeine phosphate and chlorpheniramine maleate liquid

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	23359-016
Route of Administration	ORAL	DEA Schedule	CV

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Codeine Phosphate (Codeine)	Codeine Phosphate	10 mg in 5 mL
Chlorpheniramine Maleate (Chlorpheniramine)	Chlorpheniramine Maleate	2 mg in 5 mL

Inactive Ingredients
Ingredient Name	Strength
No Inactive Ingredients Found

Product Characteristics
Color		Score
Shape		Size
Flavor	VANILLA	Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	23359-016-16	473 mL In 1 BOTTLE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		04/15/2009

Labeler - Centurion Labs (806756461)

Revised: 01/2010Centurion Labs

More Lexuss 210 Liquid resources

Lexuss 210 Liquid Side Effects (in more detail)
Lexuss 210 Liquid Dosage
Lexuss 210 Liquid Use in Pregnancy & Breastfeeding
Lexuss 210 Liquid Drug Interactions
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