Nizatidine Capsules USP 300mg Taj Pharma

Nizatidine Capsules USP 300mg Taj Pharma

1. Name of the medicinal product

Nizatidine 150mg Capsules Taj Pharma
Nizatidine 300mg Capsules Taj Pharma

2. Qualitative and quantitative composition

Each capsule contains
Nizatidine USP             150mg
Excipients                      q.s

Each capsule contains
Nizatidine USP             300mg
Excipients                      q.s

Excipient with known effect:

For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Capsule, hard

4. Clinical particulars

4.1 Therapeutic indications

For the treatment of the following diseases where reduction of gastric acid is indicated:

1) Duodenal ulcer

2) Benign gastric ulcer

3) Prevention of duodenal or benign gastric ulcer recurrence

4) Gastric oesophageal reflux disease (including erosions, ulcerations and associated heartburn)

5) Gastric and/or duodenal ulcer associated with concomitant use of non- steroidal anti-inflammatory drugs

4.2 Posology and method of administration

Posology

Adults:

1) For treatment of duodenal ulcer: the recommended daily dose is 300mg in the evening. Treatment should continue for four weeks, although this period may be reduced if healing is confirmed earlier by endoscopy. Most ulcers will heal within four weeks, but if complete ulcer healing has not occurred after four weeks therapy, patients should continue therapy for a further four weeks.

2) For the treatment of benign gastric ulcer: the recommended daily dose is 300mg in the evening for four or, if necessary, eight weeks. Prior to treatment with nizatidine, care should be taken to exclude the possibility of gastric cancer.

If preferred, the 300mg daily dose for the treatment of duodenal or benign gastric ulcer may be given as two divided doses of 150mg in the morning and evening.

3) For the prevention of duodenal or benign gastric ulcer recurrence (prophylactic maintenance therapy): the recommended daily dose is 150mg in the evening.

4) For the treatment of gastric oesophageal reflux disease: the recommended dosage is from 150mg twice daily up to 300mg twice daily. Therapy for up to 12 weeks is indicated for erosions, ulcerations and associated heartburn.

5) For the treatment of gastric and/or duodenal ulcer associated with concomitant use of non-steroidal anti-inflammatory drugs: the recommended daily dose is 300mg daily (either 300mg at bedtime or 150mg twice daily, in the morning and in the evening) for up to 8 weeks. In most patients, the ulcers will heal within 4 weeks. During treatment, the use of non-steroidal anti-inflammatory drugs may continue.

The elderly: Age does not significantly influence efficacy or safety. Normally dosage modification is not required except in patients who have moderate to severe renal impairment (creatinine clearance less than 50 ml/min).

Paediatric population: The safety and efficacy of nizatidine in children have not been established. No data are available.

Patients with impaired renal function: For patients who have moderate renal impairment (creatinine clearance less than 50 ml/min) or patients who have severe renal impairment (creatinine clearance less than 20 ml/min), the dosage should be reduced as follows:

Method of administration

For oral administration.

4.3 Contraindications

Hypersensitivity to the active substance, any other H₂-receptor antagonists or to any of the excipients listed in section 6.1.

4.4 Special warnings and precautions for use

As nizatidine is partially metabolised by the liver and principally excreted by the kidneys, patients with impaired liver or kidney function should be treated with caution. (see section 4.2.)

Symptomatic response to nizatidine therapy does not preclude the presence of gastric malignancy.

4.5 Interaction with other medicinal products and other forms of interaction

There is evidence that oral nizatidine does not affect the serum levels of concomitantly-administered aminophylline, theophylline, chlordiazepoxide, diazepam, lidocaine, phenytoin, ibuprofen, metoprolol, warfarin or lorazepam.

Nizatidine does not inhibit the hepatic cytochrome P450-linked drug metabolising enzyme system, but may increase absorption of salicylates when they are used in very high dosage. However, nizatidine and other histamine H₂– receptor antagonists can reduce the gastric absorption of drugs whose absorption is dependent on an acidic gastric pH. Approximately 35% of nizatidine is bound to plasma protein. Warfarin, diazepam, paracetamol, propantheline, phenobarbitone, and propranolol did not affect plasma protein binding of nizatidine in vitro.

Absorption of nizatidine is not clinically significantly affected by food intake, anticholinergic agents, or antacids.

4.6 Fertility, pregnancy and lactation

Pregnancy

The safety of nizatidine for use during pregnancy has not been established. Animal studies have shown no evidence of impaired fertility or teratogenicity attributable to nizatidine. Nizatidine should only be used in pregnant women, or in those planning pregnancy, if considered absolutely necessary, and then with caution.

Breast-feeding

Studies conducted in lactating women have shown that 0.1% of the administered oral dose of nizatidine is secreted in human milk in proportion to plasma concentrations. Because of the growth depression in pups reared by lactating rats treated with nizatidine, it should be administered to nursing mothers only if considered absolutely necessary.

4.7 Effects on ability to drive and use machines

There is no influence of nizatidine on the ability to drive or use machines.

4.8 Undesirable effects

In large scale clinical trials, sweating and urticaria were significantly more common in nizatidine-treated patients when compared with placebo. In these trials, 1.9% of treated patients experienced somnolence, compared to 1.6% of placebo patients (non-significant).

In the same trials, patients treated with both nizatidine and placebo had mild, transient, asymptomatic elevations of transaminases or alkaline phosphatase; rare instances of marked elevations (> 500 iu/l) occurred in nizatidine-treated patients. The overall rate of occurrences of elevated liver enzymes and elevations to 3 times the upper limit of normal, however, did not differ significantly from placebo. All abnormalities were reversible after discontinuation of nizatidine. Hepatitis and jaundice have been reported. Rare cases of cholestatic or mixed hepatocellular and cholestatic injury with jaundice have also been reported, with reversal of the abnormalities after discontinuation.

The following effects have also been rarely reported, thrombocytopenic purpura, fatal thrombocytopenia, leucopenia, agranulocytosis, anaemia, exfoliative dermatitis, vasculitis, arthralgia, myalgia, gynaecomastia, impotence, hyperuricaemia, fever, nausea and reversible mental confusion.

Rare episodes of hypersensitivity reactions (eg, bronchospasm, laryngeal oedema, rash, pruritus and eosinophilia), serum sickness and anaphylaxis have been reported.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

4.9 Overdose

Symptoms

There is little experience of overdose in humans. Tested at very high doses in animals, nizatidine has been shown to be relatively non-toxic. Animal studies suggest that cholinergic-type effects, including lacrimation, salivation, emesis, miosis and diarrhoea, may occur following very large oral doses.

Treatment

Symptomatic and supportive therapy is recommended. Activated charcoal, emesis or lavage may reduce nizatidine absorption. The ability of haemodialysis to remove nizatidine from the body has not been conclusively demonstrated. However, this method is not expected to be efficient, since nizatidine has a large volume of distribution.

5. Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Drugs for peptic ulcer and gastro-oesophageal reflux disease (GORD), H₂-receptor antagonists.

Mechanism of action

Nizatidine is a potent, selective, competitive and fully reversible histamine H₂ – receptor antagonist. Nizatidine significantly decreased basal and stimulated gastric acid and pepsin concentration, in addition to the volume of gastric secretion.

Pharmacodynamic effects

In various clinical trials, nizatidine, administered as either a single daily dose (at bedtime) or in two divided doses (morning and evening), significantly inhibited gastric acid secretion, and ulcer pain was usually rapidly abolished.

Nizatidine has no significant effect on the serum concentrations of gastrin, gonadotrophins, prolactin, growth hormone, antidiuretic hormone, cortisol, testosterone, 5-alpha-dihydrotestosterone or oestradiol.

Nizatidine has no antiandrogenic action.

5.2 Pharmacokinetic properties

Bioavailability of orally administered nizatidine is not significantly influenced by food intake, anticholinergic agents or antacids.

Absorption

Absorption of nizatidine after oral administration is rapid and peak plasma concentrations (700 – 1800 ng/ml after 150mg; 1400 – 3600 ng/ml after 300mg dose) are usually achieved within two hours of administration (range 0.5 – 3 hours). Oral bioavailability exceeds 70% and the elimination half-life is approximately 1.6 hours.

Distribution

Approximately 35 per cent of nizatidine is bound to plasma protein. Warfarin, diazepam, paracetamol, propantheline, phenobarbitone and propranolol did not affect plasma protein binding of nizatidine in vitro.

Biotransformation

Minor (6 %) first pass hepatic metabolism occurs, but nizatidine is principally excreted via the kidneys, about 60% as unchanged drug, renal clearance is about 500 ml/min. Metabolites include desmethyl nizatidine (7 %), sulphoxide (6 %) and N-oxide (5 %). Desmethyl nizatidine is an active metabolite of limited potency.

Elimination

More than 90 % of an oral dose of nizatidine (including metabolites) is excreted in the urine within 12 hours.

5.3 Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.

6. Pharmaceutical particulars

6.1 List of excipients

Capsule Contents

Croscarmellose sodium, Starch pregelatinized, Talc

Magnesium stearate

Capsule Composition

Titanium dioxide, Gelatin, Quinoline yellow, Allura red, Yellow iron oxide

Ink Composition

Shellac, Macrogol, Potassium hydroxide, Black iron oxide

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years.

6.4 Special precautions for storage

Do not store above 25°C.

6.5 Nature and contents of container

High density polyethylene bottles with polypropylene snap-on caps containing 28 or 30 capsules or PVC/Aluminium blister packs containing 28 or 30 capsules.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

No special requirements.

7. Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com

Nizatidine Capsules USP 150mg, 300mg Taj Pharma

Package leaflet: Information for the patient

Nizatidine 150 mg Capsules Taj Pharma
Nizatidine 300 mg Capsules Taj Pharma

(nizatidine)

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,  even if their signs of illness are the same as
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section

What is in this leaflet

1. What Nizatidine is and what it is used for
2. What you need to know before you take Nizatidine
3. How to take Nizatidine
4. Possible side effects
5. How to store Nizatidine
6. Contents of the pack andother information

1.         What Nizatidine is and what it is used for

Nizatidine belongs to a group of medicines called H₂-receptor antagonists (anti-ulcer medicines), which reduce the amount of acid in your stomach.

This medicine is used to:

• heal and stop ulcers in the stomach, or the part where it empties into the small intestine (duodenum)
• heal and stop problems caused by acid in the gullet (oesophagus) or too much acid in the This can cause pain or discomfort known as indigestion, acid reflux or heartburn
• prevent ulcers which may be caused by NSAID (non-steroidal anti-inflammatory drug) treatment

i.e. ibuprofen, diclofenac -often used to treat arthritis

• stop these ulcers from coming

2. What you need to know before you take Nizatidine Do not take Nizatidine:
   • if you are allergic to nizatidine or any of the other ingredients of this medicine (listed in section 6).
   • if you have taken a similar anti-ulcer medicine before and you suffered an unusual or allergic An allergic reaction may include rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue.

Warnings and precautions

Talk to your doctor or pharmacist before taking Nizatidine

• if you have liver or kidney

Other medicines and Nizatidine

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription.

• a medicine called a salicylate (i.e. aspirin), normally used to relieve minor aches and

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

You should have no problems with driving or using machines when taking this medicine.

Nizatidine contains Allura red ( 150 mg only)

May cause allergic reactions.

3.         How to take Nizatidine

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Adults (including older people)

For stomach or duodenal ulcers:

The recommended dose is 150 mg in the morning and 150 mg in the evening or 300 mg taken as a single dose in the evening for 4 weeks. If your ulcer has not fully healed after 4 weeks, your doctor will treat you for a further 4 weeks. If you are also taking a non-steroidal anti-inflammatory drug (NSAID), the recommended dose is the same as above.

To treat indigestion, acid reflux, heartburn:

The recommended dose is 150 mg to 300 mg taken twice a day for up to 12 weeks.

To prevent ulcers coming back:

The recommended dose is 150 mg taken in the evening.

Patients with kidney problems:

Your doctor may change the dose. If you have kidney problems, your doctor may prescribe a lower or less frequent dose.

Duration of treatment

It is important that you keep taking the medicine until you finish the full course of treatment.

Use in children and adolescents

Nizatidine should not be given to children or adolescents.If you take more Nizatidine than you should

Contact your doctor or nearest hospital emergency department immediately. Signs of an overdose may include watery eyes, increased saliva, being sick, narrowing of the pupils of the eyes and diarrhoea.

Take the carton or container and any remaining capsules with you.

If you forget to take Nizatidine

Take the next dose as soon as you remember unless it is almost time for your next dose. Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.              Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you notice any of these while taking this medicine, stop taking this medicine and see your doctor straight away or go to your nearest hospital emergency department immediately:

Rare (may affect up to 1 in 1,000 people)

• any kind of skin rash or ‘hives’ (small itchy spots), boils or sore lips, swelling of the face, lips, tongue, throat or other parts of the body, fever, sudden wheezing and coughing, uttering or tightness of the chest, chest pain, feeling faint and difficulty breathing due to an allergic reaction
• yellowing of the whites of the eyes or skin, dark urine, pale coloured bowel movements, itching due to problems with your liver
• bruising more easily, bleeding, particularly of the mouth and nose, or bruising under the skin. In severe cases, blood in the urine or faeces and headaches due to low platelets in your blood
• frequent infections such as fever, severe chills, sore throat or mouth ulcers due to lack of white blood cells

These side effects are rare but serious. You may need medical attention.

Other possible side effects

Common (may affect up to 1 in 10 people)

• sweating
• sleepiness

Rare (may affect up to 1 in 1,000 people)

• unusual tiredness, shortness of breath when exercising, dizziness and looking pale due to a decrease in red blood cells (anaemia).
• flaking or peeling of the skin
• narrowing or blockage of the blood vessels, causing a general feeling of being unwell, with fever, tiredness and weight loss
• joint pain, aching muscles, muscle tenderness or weakness not caused by exercise
• if you are a man, breast enlargement or an inability to get or maintain an erection
• high uric acid levels in the blood (shown on blood tests), which may cause severe pain and swelling in the joints, kidney stones (gout)
• increased liver enzymes (which may be seen in blood tests)
• fever
• nausea (feeling sick)
• confusion
• increase in some white blood cells which may be seen in a blood test

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

5.         How to store Nizatidine

Keep this medicine out of the sight and reach of children. Do not store above 25°C.

Do not use this medicine after the expiry date which is stated on the carton or container after ‘EXP’. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Nizatidine contains

The active substance is nizatidine.

Each capsule contains either 150 mg or 300 mg of nizatidine.

The other ingredients are croscarmellose sodium, pregelatinised starch, talc and magnesium stearate.

The capsule is made of gelatin, titanium dioxide, red (300 mg only) and yellow iron oxide and black printing ink (shellac, macrogol, potassium hydroxide and black iron oxide.

The 150 mg capsule also contains the colourants Allura red (see section 2 “Nizatidine contains Allura red and Quinoline yellow.

What Nizatidine looks like and contents of the pack

Your medicine comes as a hard capsule containing white to off-white powder.

Nizatidine is available in blisters and plastic containers of 28 or 30 capsules. Not all pack sizes may be marketed.

7. Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com