DepoDur Suspension

Pronunciation: MOR-feen
Generic Name: Morphine
Brand Name: DepoDur

DepoDur Suspension is used for:

Treating pain following surgery. It may also be used for other conditions as determined by your doctor.

DepoDur Suspension is a narcotic pain reliever. It works in the brain to decrease pain. It may also affect other body systems (eg, breathing and circulatory systems) at higher doses.

Do NOT use DepoDur Suspension if:

• you are allergic to any ingredient in DepoDur Suspension


• you have severe diarrhea, bowel problems caused by antibiotics or food poisoning, a blockage of your stomach or bowel, or certain other severe bowel problems (eg, bowel paralysis)


• you have difficult or slowed breathing, severely decreased blood circulation (circulatory shock), a recent head injury, growths in the brain (eg, tumors), or increased pressure in the brain


• if you have severe asthma, or if you are having an asthma attack


• you are taking a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) or if you have taken an MAOI within the past 14 days


• you are taking sodium oxybate (GHB)

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

Before using DepoDur Suspension:

Some medical conditions may interact with DepoDur Suspension. 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 a history of lung or breathing problems (eg, asthma, emphysema, bronchitis, chronic obstructive pulmonary disease [COPD]), sleep apnea (you stop breathing when you sleep), curvature of the spine (eg, kyphoscoliosis), heart problems (eg, cor pulmonale), low blood pressure, dehydration, or low blood volume


• if you have liver problems, kidney problems, adrenal gland problems (eg, Addison disease), an underactive thyroid, a blockage of your bladder, an enlarged prostate, or trouble urinating


• if you have a history of bowel blockage or other stomach or bowel problems (eg, inflammation), pancreas or gallbladder problems, or recent stomach or bowel surgery


• if you have severe drowsiness or a history of seizures (eg, epilepsy)


• if you drink alcohol regularly, have symptoms of alcohol withdrawal, or have a history of suicidal thoughts or attempts


• if you have a personal or family history of mental or mood problems, alcohol abuse, or other substance abuse or dependence


• if you are in poor health or are overweight

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

• Antiemetics (eg, metoclopramide), phenothiazines (eg, chlorpromazine), sleeping medicines (eg, zolpidem), or tranquilizers (eg, olanzapine) because the risk of breathing problems, low blood pressure, severe drowsiness, or coma may be increased


• Barbiturate anesthetics (eg, thiopental), cimetidine, MAOIs (eg, phenelzine), muscle relaxants (eg, carisoprodol), or sodium oxybate (GHB) because the risk of confusion, severe drowsiness, severe breathing problems, and coma may be increased


• Mixed narcotic agonists/antagonists (eg, pentazocine), naltrexone, or rifampin because they may decrease DepoDur Suspension's effectiveness


• Diuretics (eg, furosemide, hydrochlorothiazide) or trovafloxacin because their effectiveness may be decreased by DepoDur Suspension

This may not be a complete list of all interactions that may occur. Ask your health care provider if DepoDur Suspension 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 DepoDur Suspension:

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

• DepoDur Suspension is usually given as an injection at your doctor's office, hospital, or clinic.


• If you miss a dose of DepoDur Suspension contact your doctor.

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

Important safety information:

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


• Do not drink alcohol while you are using DepoDur Suspension.


• Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using DepoDur Suspension; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• DepoDur Suspension may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.


• Tell your doctor or dentist that you received DepoDur Suspension before you have any medical or dental care, emergency care, or surgery.


• Lab tests, including liver function, kidney function, lung function, and complete blood cell counts, may be performed while you use DepoDur Suspension. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use DepoDur Suspension with caution in the ELDERLY; they may be more sensitive to its effects, especially severe breathing problems.


• DepoDur Suspension should not be used in CHILDREN younger than 18 years old; safety and effectiveness in these 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 DepoDur Suspension while you are pregnant. DepoDur Suspension is found in breast milk. Check with your doctor to see whether or not you should breast-feed within 48 hours after receiving DepoDur Suspension.

When used for long periods of time or at high doses, DepoDur Suspension may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if DepoDur Suspension stops working well. Do not take more than prescribed.

Some people who use DepoDur Suspension for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction.

If you stop taking DepoDur Suspension suddenly, you may have WITHDRAWAL symptoms. These may include anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.

Possible side effects of DepoDur Suspension:

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; dizziness; drowsiness; headache; lightheadedness; nausea; vomiting; weakness.

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); confusion; delirium; difficulty urinating; disorientation; fainting; fast, slow, or irregular heartbeat; fever; flushing of the face; hallucinations; mood or mental changes; numbness or tingling; seizures; severe dizziness or lightheadedness; severe drowsiness; severe or persistent vomiting or constipation, shortness of breath; slowed or difficult breathing; tremor; trouble sleeping; unusual sweating; 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.

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. Symptoms may include cold and clammy skin; convulsions; deep sleep; dizziness; lightheadedness; loss of consciousness; severe drowsiness; slowed breathing; slowed heartbeat.

Proper storage of DepoDur Suspension:

DepoDur Suspension is usually handled and stored by a health care provider. If you are using DepoDur Suspension at home, store DepoDur Suspension as directed by your pharmacist or health care provider.

General information:

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


• DepoDur Suspension 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 DepoDur Suspension. 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

Copyright © 2012 Wolters Kluwer Health, Inc.

Dacarbazine

Pronunciation: da-KAR-ba-zeen
Generic Name: Dacarbazine
Brand Name: DTIC-Dome

Dacarbazine can cause severe, even fatal, liver problems (hepatic necroses), or a decrease in the formation of new blood cells (hemopoietic depression). It has also caused cancer and birth defects in laboratory animals. Notify your doctor immediately if you develop symptoms of an infection (eg, persistent sore throat or fever), easy bruising or bleeding, nausea, dark urine, unusual fatigue, yellowing of the eyes or skin, or stomach pain. Your doctor will monitor you closely while you are using Dacarbazine.

Dacarbazine is used for:

Treating certain cancers (eg, advanced skin cancer) and Hodgkin disease. It may be used with other medicines. It may also be used for other conditions as determined by your doctor.

Dacarbazine is an antineoplastic agent. It is not known exactly how Dacarbazine works. It may block the growth of cancer cells.

Do NOT use Dacarbazine if:

• you are allergic to any ingredient in Dacarbazine


• you have shingles or chickenpox

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

Before using Dacarbazine:

Some medical conditions may interact with Dacarbazine. 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 a blood disease, an infection, or liver or kidney problems

Some MEDICINES MAY INTERACT with Dacarbazine. However, no specific interactions with Dacarbazine are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Dacarbazine 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 Dacarbazine:

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

• Dacarbazine will be administered as an injection at your doctor's office, hospital, or clinic.


• If Dacarbazine contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.


• If nausea, vomiting, or loss of appetite occurs, ask your doctor or pharmacist for ways to lessen these effects.


• Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.


• If you miss a dose of Dacarbazine, contact your doctor immediately.

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

Important safety information:

• Dacarbazine may lower your body's ability to fight infection. Prevent infection by avoiding contact with people with colds or other infections. Notify your doctor of any signs of infection, including fever, sore throat, rashes, or chills.


• Dacarbazine may reduce the number of clot-forming cells (platelets) in your blood. To prevent bleeding, avoid situations in which bruising or injury may occur. Report any unusual bleeding, bruising, blood in stools, or dark, tarry stools to your doctor.


• Use of Dacarbazine may increase the risk of developing a second cancer. Discuss any questions or concerns with your doctor.


• Avoid vaccination with live virus vaccines (eg, measles, mumps, oral polio) while you are taking Dacarbazine. Vaccinations may be less effective.


• LAB TESTS, including blood cell counts and liver function tests, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Dacarbazine during pregnancy. It is unknown if Dacarbazine is excreted in breast milk. Do not breast-feed while taking Dacarbazine.

Possible side effects of Dacarbazine:

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:

Facial flushing, numbness, or tingling; loss of appetite; metallic taste in mouth; muscle pain or weakness; nausea; temporary hair loss; vomiting.

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dark urine; fever, chills, or sore throat; joint pain; pain, redness, or swelling at injection site; severe nausea and vomiting; stomach pain; unusual bruising or bleeding; unusual tiredness or weakness; yellowing of skin or eyes.

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: Dacarbazine 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 (http://www.aapcc.org ), or emergency room immediately.

Proper storage of Dacarbazine:

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

General information:

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


• Dacarbazine 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 Dacarbazine. 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

Copyright © 2012 Wolters Kluwer Health, Inc.

More Dacarbazine resources

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

• Dacarbazine Prescribing Information (FDA)


• Dacarbazine Monograph (AHFS DI)


• Dacarbazine Professional Patient Advice (Wolters Kluwer)


• dacarbazine Concise Consumer Information (Cerner Multum)


• dacarbazine Intravenous, Injection Advanced Consumer (Micromedex) - Includes Dosage Information

Compare Dacarbazine with other medications

• Hodgkin's Lymphoma
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Diidrocodeina

Diidrocodeina may be available in the countries listed below.

Ingredient matches for Diidrocodeina

Dihydrocodeine

Diidrocodeina (DCIT) is known as Dihydrocodeine in the US.

International Drug Name Search

Glossary

DCIT	Denominazione Comune Italiana

Click for further information on drug naming conventions and International Nonproprietary Names.

Elecare

Pronunciation: a-MEE-no AS-id nu-TRISH-un-al SUP-le-ment
Generic Name: Amino Acid-Based Nutritional Supplement
Brand Name: Elecare

Elecare is used for:

Providing nutrition in certain patients with severe food allergies or other conditions such as eosinophilic GI disorders (EGID), short bowel syndrome, or malabsorption in which an amino acid-based diet is required.

Elecare is a nutritionally complete amino acid-based medical food. It provides nutrition for certain patients who cannot tolerate intact or hydrolyzed protein.

Do NOT use Elecare if:

• you are allergic to any ingredient in Elecare

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

Before using Elecare:

Some medical conditions may interact with Elecare. 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

Some MEDICINES MAY INTERACT with Elecare. However, no specific interactions with Elecare are known at this time.

Ask your health care provider if Elecare 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 Elecare:

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

• Elecare may be taken by mouth or through a feeding tube.


• Elecare must be mixed with water before you take it.


• Shake well before each use.


• Use the measuring scoop provided with Elecare. Ask your pharmacist for help if you are unsure of how to mix Elecare.


• If you miss a dose of Elecare, take it as soon as you remember. Continue to take it as directed by your doctor or on the package label.

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

Important safety information:

• Do not take large doses of vitamins while you use Elecare unless your doctor tells you to.


• Do not change brands of Elecare without talking to your doctor. Products made by other companies may not work as well for you.


• Diabetes patients - Some brands of Elecare may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


• Keep all doctor and lab appointments while you use Elecare.


• Before you start any new medicine, either prescription or over-the-counter, check with your doctor or pharmacist.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Elecare while you are pregnant. It is not known if Elecare is found in breast milk. If you are or will be breast-feeding while you use Elecare, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Elecare:

All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with this product. 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).

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: Elecare 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 Elecare:

Store unopened cans of Elecare at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Once mixed, store Elecare in the refrigerator, between 35 and 40 degrees F (2 and 4 degrees C) and use within 24 hours. Do not freeze. Store away from heat, moisture, and light. Do not store in the bathroom. Use opened can contents within 1 month. Keep Elecare out of the reach of children and away from pets.

General information:

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


• Elecare 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 Elecare. 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

Copyright © 2012 Wolters Kluwer Health, Inc.

More Elecare resources

• Elecare Side Effects (in more detail)
• Elecare Support Group
• 0 Reviews for Elecare - Add your own review/rating

Compare Elecare with other medications

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Tagamet 400mg Tablets

1. Name Of The Medicinal Product

Tagamet 400 mg Tablets

2. Qualitative And Quantitative Composition

Each tablet contains Cimetidine 400 mg.

For excipients, see 6.1.

3. Pharmaceutical Form

Film-coated tablet.

Pale green, oblong, film-coated tablet embossed with Tagamet on one side and 400 on the reverse.

4. Clinical Particulars

4.1 Therapeutic Indications

Tagamet is a histamine H₂-receptor antagonist which rapidly inhibits both basal and stimulated gastric secretion of acid and reduces pepsin output.

Tagamet is indicated in the treatment of duodenal and benign gastric ulceration, including that associated with non-steroidal anti-inflammatory agents, recurrent and stomal ulceration, oesophageal reflux disease and other conditions where reduction of gastric acid by Tagamet has been shown to be beneficial: persistent dyspeptic symptoms with or without ulceration, particularly meal-related upper abdominal pain, including such symptoms associated with non-steroidal anti-inflammatory agents; the prophylaxis of gastrointestinal haemorrhage from stress ulceration in critically ill patients; before general anaesthesia in patients thought to be at risk of acid aspiration (Mendelson's) syndrome, particularly obstetric patients during labour; to reduce malabsorption and fluid loss in the short bowel syndrome; and in pancreatic insufficiency to reduce degradation of enzyme supplements. Tagamet is also recommended in the management of the Zollinger-Ellison syndrome.

4.2 Posology And Method Of Administration

The total daily dose should not normally exceed 2.4g. Dosage should be reduced in patients with impaired renal function (see section 4.4)

Adults: The usual dosage is 400mg twice a day with breakfast and at bedtime. Alternatively,for patients with duodenal or benign gastric ulceration, a single daily dose of 800mg at bedtime can be used. Other effective regimens are 200mg three times a day with meals and 400mg at bedtime (1.0g/day) and, if inadequate, 400mg four times a day (1.6g/day) also with meals and at bedtime.

Treatment should be given initially for at least four weeks (six weeks in benign gastric ulcer, eight weeks in ulcer associated with continued non-steroidal anti-inflammatory agents) even if symptomatic relief has been achieved sooner. Most ulcers will have healed by that stage, but those which have not will usually do so after a further course of treatment.

Treatment may be continued for longer periods in those patients who may benefit from reduction of gastric secretion and the dosage may be reduced in those who have responded to treatment, for example to 400mg at bedtime; or 400mg in the morning and at bedtime.

In patients with benign peptic ulcer disease who have responded to the initial course, relapse may be prevented by continued treatment, usually with 400mg at bedtime; 400mg in the morning and at bedtime has also been used.

In oesophageal reflux disease, 400mg four times a day, with meals and at bedtime, for four to eight weeks is recommended to heal oesophagitis and relieve associated symptoms.

In patients with very high gastric acid secretion (e.g. Zollinger-Ellison syndrome) it may be necessary to increase the dose to 400mg four times a day, or in occasional cases further.

Antacids can be made available to all patients until symptoms disappear.

In the prophylaxis of haemorrhage from stress ulceration in seriously ill patients, doses of 200-400mg can be given every four to six hours.

In patients thought to be at risk of acid aspiration syndrome an oral dose of 400mg can be given 90-120 minutes before induction of general anaesthesia or, in obstetric practice, at the start of labour. While such a risk persists, a dose of up to 400mg may be repeated at four hourly intervals as required up to the usual daily maximum of 2.4g. The usual precautions to avoid acid aspiration should be taken.

In the short bowel syndrome, e.g. following substantial resection for Crohn's disease, the usual dosage range (see above) can be used according to individual response.

To reduce degradation of pancreatic enzyme supplements, 800-1600mg a day may be given according to response in four divided doses, one to one and a half hours before meals.

Elderly: The normal adult dosage may be used unless renal function is markedly impaired. (see Section 4.4).

Children: Experience in children is less than that in adults. In children more than one year old, Tagamet 25-30mg/kg body weight per day in divided doses may be administered.

The use of Tagamet in infants under one year old is not yet fully evaluated; 20mg/kg body weight per day in divided doses has been used.

Administration: Oral; the tablets should be swallowed with a drink of water.

4.3 Contraindications

Hypersensitivity to cimetidine.

4.4 Special Warnings And Precautions For Use

Dosage should be reduced in patients with impaired renal function according to creatinine clearance. The following dosages are suggested: creatinine clearance of 0-15ml per minute, 200mg twice a day; 15 to 30ml per minute, 200mg three times a day; 30 to 50ml per minute, 200mg four times a day; over 50ml per minute, normal dosage. Cimetidine is removed by haemodialysis, but not to any significant extent by peritoneal dialysis.

Clinical trials of over six years' continuous treatment and more than 15 years' widespread use have not revealed unexpected adverse reactions related to long-term therapy

The safety of prolonged use is not fully established and care should be taken to observe periodically patients given prolonged treatment.

Care should be taken that patients with a history of peptic ulcer, particularly the elderly, being treated with cimetidine and a non-steroidal anti-inflammatory agent are observed regularly.

Before initiating therapy with this preparation for any gastric ulceration, malignancy should be excluded by endoscopy and biopsy, if possible, because Tagamet tablets can relieve the symptoms and help the superficial healing of the gastric cancer. The consequences of potential delay in diagnosis should be borne in mind especially in middle aged patients or over, with new or recently changed dyspeptic symptoms.

Due to possible interaction with coumarins, close monitoring of prothrombin time is recommended when cimetidine is concurrently used.

Co-administration of therapeutic agents with a narrow therapeutic index, such as phenytoin or theophylline, may require dosage adjustment when starting or stopping concomitantly administered cimetidine (see Section 4.5).

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Cimetidine can prolong the elimination of drugs metabolised by oxidation in the liver.

Although pharmacological interactions between cimetidine and a number of drugs have been demonstrated e.g. diazepam and propranolol, only those with oral anticoagulants, phenytoin, theophylline and intravenous lidocaine appear, to date, to be of clinical significance. Close monitoring of patients on cimetidine receiving oral anticoagulants or phenytoin is recommended and a reduction in the dosage of these drugs may be necessary.

In patients on drug treatment or with illnesses that could cause falls in blood cell count, the possibility that H₂-receptor antagonism could potentiate this effect should be borne in mind.

Cimetidine has the potential to affect the absorption, metabolism or renal excretion of other drugs which is particularly important when drugs with a narrow therapeutic index are administered concurrently. The altered pharmacokinetics may necessitate dosage adjustment of the affected drug or discontinuation of treatment (see Section 4.4).

Interactions may occur by several mechanisms including:

1) Inhibition of certain cytochrome P450 enzymes (including CYP1A2, CYP2C9, CYP2D6 and CYP3A3/A4, and CYP2C18); Inhibition of these enzymes may result in increased plasma levels of certain drugs including warfarin-type coumarin anticoagulants (e.g. warfarin), tricyclic antidepressants (e.g. amitriptyline), class I antiarrhythmics (e.g. lidocaine), calcium channel blockers (e.g. nifedipine, diltiazem), oral sulfonylureas (e.g. glipizide), phenytoin, theophylline and metoprolol.

2) Competition for renal tubular secretion; This may result in increased plasma levels of certain drugs including procainamide, metformin, ciclosporin and tacrolimus.

3) Alteration of gastric pH; The bioavailability of certain drugs may be affected. This can result in either an increase in absorption (e.g. atazanavir) or a decrease in absorption (e.g. some azole antifungals such as ketoconazole, itraconazole or posaconazole).

4) Unknown mechanisms; Cimetidine may potentiate the myelosuppressive effects (e.g. neutropenia, agranulocytosis) of chemotherapeutic agents such as carmustine, fluorouracil, epirubicin, or therapies such as radiation. Isolated cases of clinically relevant interactions have been documented with narcotic analgesics (e.g. morphine).

4.6 Pregnancy And Lactation

Although tests in animals and clinical evidence have not revealed any hazards from the administration of Tagamet during pregnancy or lactation, both animal and human studies have shown that it does cross the placental barrier and is excreted in milk. The use of this preparation during pregnancy and lactation should be avoided unless considered essential by the physician.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Adverse experiences with cimetidine are listed below by system organ class and frequency. Frequencies are defined as: very common (>1/10), common (>1/100, <1/10), uncommon (>1/1000, <1/100), rare (>1/10000, <1/1000), very rare (<1/10000).

Blood and lymphatic system disorders

Uncommon: Leukopenia

Rare: Thrombocytopenia, aplastic anaemia

Very rare: Pancytopenia, agranulocytosis

Immune system disorders

Very rare: Anaphylaxis. Anaphylaxis is usually cleared on withdrawal of the drug.

Psychiatric disorders

Uncommon: Depression, confusional states, hallucinations. Confusional states, reversible within a few days of withdrawing cimetidine, have been reported, usually in elderly or ill patients.

Nervous system disorders

Common: Headache, dizziness

Cardiac disorders

Uncommon: Tachycardia

Rare: Sinus bradycardia

Very rare: Heart block

Gastrointestinal disorders

Common: Diarrhoea

Very rare: Pancreatitis. Pancreatitis cleared on withdrawal of the drug.

Hepatobiliary disorders

Uncommon: Hepatitis

Rare: Increased serum transaminase levels. Hepatitis and increased serum transaminase levels cleared on withdrawal of the drug.

Skin and subcutaneous tissue disorders

Common: Skin rashes

Very rare: Reversible alopecia and hypersensitivity vasculitis. Hypersensitivity vasculitis usually cleared on withdrawal of the drug.

Musculoskeletal and connective tissue disorders

Common: Myalgia

Very rare: Arthralgia

Renal and urinary disorders

Uncommon: Increases in plasma creatinine

Rare: Interstitial nephritis. Interstitial nephritis cleared on withdrawal of the drug. Small increases in plasma creatinine have been reported, unassociated with changes in glomerular filtration rate. The increases do not progress with continued therapy and disappear at the end of therapy.

Reproductive system and breast disorders

Uncommon: Gynaecomastia and reversible impotence. Gynaecomastia is usually reversible upon discontinuation of cimetidine therapy. Reversible impotence has been reported particularly in patients receiving high doses (e.g. in Zollinger-Ellison Syndrome). However, at regular dosage, the incidence is similar to that in the general population.

Very rare: Galactorrhoea

General disorders and administration site conditions

Common: Tiredness

Very rare: Fever. Fever cleared on withdrawal of the drug.

4.9 Overdose

Acute overdosage of up to 20g has been reported several times with no significant ill-effects. Induction of vomiting and/or gastric lavage may be employed together with symptomatic and supportive therapy.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Cimetidine, one of the H2 blockers is a reversible, competitive antagonist of the actions of histamine on H2 receptors. It is highly selective in its action and is virtually without effect on H1 receptors or, indeed on receptors for other autacoids or drugs. The most prominent of the effects of histamine that are mediated by H2 receptors is stimulation of gastric acid secretion and they interfere remarkably little with physiological functions other than gastric secretion.

Cimetidine inhibits gastric acid secretion elicited by histamine or other H2 agonists in a dose-dependent, competitive manner; the degree of inhibition parallels the plasma concentration of the drug over a wide range. In addition, the H2 blockers inhibit gastric secretion elicited by muscarinic agonists or by gastrin, although this effect is not always complete.

This breadth of inhibitory effect is not due to non-specific actions at the receptors for these other secretagogues. Rather, this effect, which is non-competitive and indirect, appears to indicate either that these two classes of secretagogues utilise histamine as the final common mediator or, more probably, that ongoing histaminergic stimulation of the parietal cell is important for amplification of the stimuli provided by ACh or gastrin when they act on their own discrete receptors. Receptors for all three secretagogues are present on the parietal cell. The ability of H2 blockers to suppress responses to all three physiological secretagogues makes them potent inhibitors of all phases of gastric acid secretion. Thus these drugs will inhibit basal (fasting) secretion and nocturnal secretion and also that stimulated by food, sham feeding, fundic distension, insulin, or caffeine. The H2 blockers reduce both the volume of gastric juice secreted and its hydrogen ion concentration. Output of pepsin, which is secreted by the chief cells of the gastric glands (mainly under cholinergic control), generally falls in parallel with the reduction in volume of the gastric juice. Secretion of intrinsic factor is also reduced, but it is normally secreted in great excess, and absorption of vitamin B12 is usually adequate even during long-term therapy with H2 blockers.

Concentrations of gastrin in plasma are not significantly altered under fasting conditions; however, the normal prandial elevation of gastrin concentration may be augmented, apparently as a consequence of a reduction in the negative feedback that is normally provided by acid.

5.2 Pharmacokinetic Properties

Cimetidine is rapidly and virtually completely absorbed. Absorption is little impaired by food or by antacids. Peak concentrations in plasma are attained in about 1 to 2 hours. Hepatic first-pass metabolism results in bioavailabilities of about 60% for cimetidine. The elimination half-life is about 2 to 3 hours. Cimetidine is eliminated primarily by the kidneys, and 60% or more may appear in the urine unchanged; much of the rest is oxidation products. Small amounts are recovered in the stool.

5.3 Preclinical Safety Data

Not available.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Microcrystalline cellulose

Povidone 30

Sodium starch glycollate

Sodium lauryl sulphate

Colloidal anhydrous silica

Magnesium stearate

Hypromellose (E464)

Titanium dioxide (E171)

Macrogol 400

Indigo carmine aluminium lake (E132)

Iron oxide yellow (E172)

Quinoline yellow aluminium lake (E104).

6.2 Incompatibilities

Not applicable

6.3 Shelf Life

3 years

6.4 Special Precautions For Storage

1. Blister: Do not store above 25°C. Store in the original package. Keep blister in the outer carton.

2. Tablet container (polypropylene tube): Do not store above 25°C. Keep the container tightly closed. Store in the original container.

6.5 Nature And Contents Of Container

1. Blister packs consisting of 250µm clear PVC and 20µm hard temper aluminium foil -contained in a carton.

Pack sizes: 60 tablets.

2. Polypropylene tubes with low density polyethylene caps. High density polyethylene film may be used as packing material.

Pack sizes: 56, 100, 250, 500 & 1000 tablets.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

Administrative Data

7. Marketing Authorisation Holder

Chemidex Pharma Limited

Chemidex House,

Egham BusinessVillage,

Crabtree Road,

Egham,

Surrey TW20 8RB

United Kingdom

8. Marketing Authorisation Number(S)

PL 17736/0021

9. Date Of First Authorisation/Renewal Of The Authorisation

23 December 2002

10. Date Of Revision Of The Text

February 2009

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