Ranitidine Tablets

Ranitidine Tablets

Product Name : Ranitidine tablet

Nombre del Producto: Ranitidina tableta

Specification: 150mg

Package: 10tablets/blister/box, 1blister/box, 10blister/box

Standard: BP & USP& CP

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Details

Ranitidine tablets

Therapeutic indications

Adults

Ranitidine tablets are indicated for the treatment of benign gastric ulcers and duodenal ulcers, including that associated with non-steroidal anti-inflammatory agents.

Prevention of non-steroidal anti-inflammatory drug (NSAID) (including aspirin) associated duodenal ulcers, especially in patients with a history of peptic ulcer disease.

Treatment of duodenal ulcers associated with Helicobacter pylori infection.

Post-operative ulcer.

Oesophageal reflux disease including long term management of healed oesophagitis.

Symptomatic relief in gastro-oesophageal reflux disease.

Zollinger-Ellison Syndrome

Chronic episodic dyspepsia, characterised by pain (epigastric or retrosternal) which is related to meals or disturbs sleep but not associated with the above conditions.

Prophylaxis of gastrointestinal haemorrhage from stress ulceration in seriously ill patients

Prophylaxis of recurrent haemorrhage with bleeding peptic ulcers.

Before general anaesthesia in patients at risk of acid aspiration (Mendelson's syndrome), particularly obstetric patients during labour.

Ranitidine tablets are indicated for the long-term treatment of duodenal and benign gastric ulcers to prevent their recurrence. Long-term treatment is indicated in patients with a history of recurrent ulcers.

Children (3 to 18 years)

• Short term treatment of peptic ulcer

• Treatment of gastro-oesophageal reflux, including reflux oesophagitis and symptomatic relief of gastro-oesophageal reflux disease.

 

Posology and method of administration

Adults and adolescents (12 years and older)

The usual dose is 150 mg twice daily, taken in the morning and evening.

Duodenal ulcer, gastric ulcer:

The standard dosage regimen is 150 mg twice daily or 300 mg at night. It is not necessary to time the dose in relation to meals.

In most cases of duodenal ulcer, benign gastric ulcer and post-operative ulcer, healing occurs within 4 weeks. Healing usually occurs after a further 4 weeks of treatment in those not fully healed after the initial course of therapy.

Ulcers following NSAID therapy or associated with continued NSAIDs:

8 weeks treatment may be necessary

Prevention of NSAID associated duodenal ulcers:

150 mg twice daily may be given concomitantly with NSAID therapy.

In duodenal ulcer, 300 mg twice daily for 4 weeks results in healing rates which are higher than those at 4 weeks with ranitidine 150 mg twice daily or 300 mg at night. The increased dose has not been associated with an increased incidence of unwanted effects.

Duodenal ulcers associated with Helicobacter pylori infection:

For duodenal ulcers associated with Helicobacter pylori infection, ranitidine 300 mg at bedtime or 150 mg twice daily may be given with oral amoxicillin 750 mg three times daily and metronidazole 500 mg three times daily for two weeks. Therapy with ranitidine should continue for a further two weeks. This dose regimen significantly reduces the frequency of duodenal ulcer recurrence.

Maintenance treatment at a reduced dosage of 150 mg at bedtime is recommended for patients who have responded to short term therapy, particularly those with a history of recurrent ulcer.

Gastro-oesophageal reflux disease:

Symptom relief in gastro-oesophageal reflux disease.

In patients with gastro-oesophageal reflux disease, a dose regimen of 150 mg twice daily for 2 weeks is recommended and this can be repeated in patients in whom the initial symptomatic response is inadequate

Oesophageal reflux disease:

For the management of reflux oesophagitis, the recommended dose is 150 mg twice daily or 300 mg at bedtime, usually for up to 8 weeks, this may be extended to a maximum of 12 weeks if necessary.

Moderate to severe Oesophagitis:

The dosage of ranitidine may be increased to 150 mg, four times a day for up to a maximum of 12 weeks. This raised level of dosing has not been associated with a raised level of side effects.

Healed oesophagitis:

For long term treatment, recommended adult dose is 150 mg twice daily. Long-term treatment in patients with unhealed oesophagitis is not indicated, either in the presence of Barrett's epithelium or its absence.

Zollinger-Ellison Syndrome:

An initial dose of 150 mg, three times a day, may be increased up to 300 mg three times a day. Daily divided doses of up to 6g have been used and found to be well tolerated.

Chronic episodic dyspepsia:

The standard dosage regimen for patients with chronic episodic dyspepsia is 150 mg twice daily for up to 6 weeks. Anyone not responding or relapsing shortly afterwards should be investigated.

Prophylaxis of haemorrhage from stress ulceration in seriously ill patients or prophylaxis of recurrent haemorrhage in patients bleeding from peptic ulceration:

150 mg twice daily may be substituted for the injection once oral feeding commences.

Prophylaxis of acid aspiration (Mendelson's) syndrome:

150 mg oral dose can be given 2 hours before anaesthesia, and preferably also 150 mg the previous evening. Alternatively, the injection is also available. In obstetric patients in labour 150 mg every 6 hours, but if general anaesthesia is required it is recommended that a non-particulate antacid (e.g. sodium citrate) be given in addition. The usual precautions to avoid acid aspiration should also be taken.

Children 12 years and over

For children 12 years and over the adult dosage is given.

Patients over 50 years of age

See Section 5.2 Pharmacokinetic Properties (Special Patient Populations, Patients over 50 years of age)

Children from 3 to 11 years and over 30 kg of weight

See section 5.2 Pharmacokinetic properties – Special Patient Populations.

Peptic Ulcer Acute Treatment

The recommended oral dose for the treatment of peptic ulcer in children is 4 mg/kg/day to 8 mg/kg/day administered as two divided doses to a maximum of 300 mg ranitidine per day for a duration of 4 weeks. For those patients with incomplete healing, another 4 weeks of therapy is indicated, as healing usually occurs after eight weeks of treatment.

Gastro-Oesophageal Reflux

The recommended oral dose for the treatment of gastro-oesophageal reflux in children is 5 mg/kg/day to 10 mg/kg/day administered as two divided doses in a maximum dose of 600 mg (the maximum dose is likely to apply to heavier children or adolescents with severe symptoms).

Neonates

Safety and efficacy in new-born patients has not been established.

Renal Impairment:

In patients with severe renal impairment, plasma levels of the drug are increased. The dose in such patients is 150 mg at night for 4-8 weeks. The same dose is used for maintenance. If healing has not occurred, 150 mg twice daily should be used, followed by 150 mg at night for maintenance.

Creatinine clearance

mL/min. Dose of ranitidine

<50 150 mg

>50 300 mg

Ranitidine is removed by hemodialysis. Dialysis patients should therefore take Ranitidine after each dialysis occasion.

Method of Administration

The tablet should be swallowed whole with a sufficient amount of fluid. In children the tablets may be dissolved in water or crushed. The application of a more convenient dosage form may be considered.

 

Contraindications

Hypersensitivity to ranitidine or any component of Ranitidine Tablets.

 

Special warnings and precautions for use

Malignancy:

Treatment with histamine H2·receptor antagonists may mask symptoms of stomach carcinoma and therefore delay its diagnosis of the condition. Accordingly, where gastric ulcer has been diagnosed , or in patients of middle age and over with new or recently changed dyspeptic symptoms the possibility of malignancy should be excluded before therapy with ranitidine Tablets is instituted

Renal disease:

Ranitidine is excreted via the kidney and so plasma levels of the drug are increased in patients with severe renal impairment. The dose should be adjusted as detailed above under Dosage in Renal Impairment.

Regular supervision of patients who are taking non-steroidal anti-inflammatory drugs concomitantly with ranitidine is recommended, especially in the elderly. Current evidence shows that ranitidine protects against NSAID associated ulceration in the duodenum and not in the stomach.

Although clinical reports of acute intermittent porphyria associated with ranitidine administration have been rare and inconclusive, ranitidine should be avoided in patients with a history of this condition.

Use in elderly patients:

Rates of healing of ulcers in clinical trial patients aged 65 and over have not been found to differ from those in younger patients. Additionally, there was no difference in the incidence of adverse effects.

In patients such as the elderly, persons with chronic lung disease, diabetes or the immunocompromised, there may be an increased risk of developing community acquired pneumonia. A large epidemiological study showed an increased risk of developing community acquired pneumonia in current users of H2 receptor antagonists versus those who had stopped treatment, with an observed adjusted relative risk increase of 1.63 (95% CI, 1.07–2.48). Postmarketing data indicate reversible mental confusion, depression, and hallucinations have been reported most frequently in severely ill and elderly patients .

 

Interaction with other medicinal products and other forms of interaction

Ranitidine has the potential to affect the absorption, metabolism or renal excretion of other drugs. The altered pharmacokinetics may necessitate dosage adjustment of the affected drug or discontinuation of treatment

Interactions occur by several mechanisms including:

1) Inhibition of cytochrome P450-linked mixed function oxygenase system:

Ranitidine at usual therapeutic doses does not potentiate the actions of drugs which are inactivated by this enzyme system such as diazepam, lidocaine, phenytoin, propanolol and theophylline.

There have been reports of altered prothrombin time with coumarin anticoagulants (e.g. warfarin). Due to the narrow therapeutic index, close monitoring of increased or decreased prothrombin time is recommended during concurrent treatment with ranitidine.

2) Competition for renal tubular secrection:

Since ranitidine is partially eliminated by the cationic system, it may affect the clearance of other drugs eliminated by this route. High doses of ranitidine (e.g. such as those used in the treatment of Zollinger-Ellison syndrome) may reduce the excretion of procainamide and N-acetylprocainamide resulting in increased plasma level of these drugs.

3) Alteration of gastric pH:

The bioavailability of certain drugs may be affected. This can result in either an increase in absorption (e.g. triazolam, midazolam, glipizide) or a decrease in absorption (e.g. ketoconazole, atazanavir, delaviridine, gefitnib).

There is no evidence of an interaction between ranitidine and -amoxicillin or metronidazole


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