RANI 150 mg
Effervescent Granules
Composition:
Each sachet contains :
Active Ingredient: ranitidine (as hydrochloride) 150 mg
Inactive Ingredients: Sodium bicarbonate anhydrous, Citric acid anhydrous, Tartaric acid anhydrous, Povidone K30, Aspartame, Disodium edetale, Sunset ye11ow, Orange oil, Tutti Frutti
Indications:
– Duodenal ulcer and benign gastric ulcer, including that associated with non-steroidal anti-inflammatory agents.
– Prevention of non-steroidal anti-inflammatory drug (including aspirin) associated duodenal ulcers, especially in patients with a history of peptic ulcer disease.
– Duodenal ulcer associated with Helicobacter pylori infection.
Post-operative ulcer.
– Reflux oesophagitis.
– Symptom relief in gastro-oesophageal reflux disease.
– Zollinger-Ellison Syndrome.
– Chronic episodic dyspepsia, characterized by pain (epigastric or retrosternal) which is related to meals or disturbs sleep IxJt not associated with the above conditions.
– Prophylaxis of stress ulceration in seriously ill patients.
– Prophylaxis of recurrent haemorrhage from peptic ulcer.
– Prophylaxis of Mendelson’s syndrome.
Dosage and Administration :
Rani eHervescent granules should be placed in half a glass of water (minimum 75 ml) and allowed to dissolve completely before swallowing, swirl the glass if necessary. For 300 mg doses a
volume of 150 ml is recommended. Rani effervescent granules contain aspartame.
Adults: DUODENAL ULCER AND BENIGN GASTRIC ULCER: Acute treatment
The standard dosage regimen for duodenal or benign gastric ulcer is 150 mg twice daily or 300 mg at nigh!. In most cases of duodenal ulcer or benign gastric ulcer healing occurs within four weeks. Healing usually occurs after a further four weeks in those not fully healed after the initial four weeks.
In duodenal ulcer 300 mg twice daily for four weeks results in healing rates are higher than those at four weeks with Rani 150 mg twice daily or 300 mg at night. The increased dose has not been associated with an increased incidence of unwanted eHects.
Long-term management: For the long-term management of duodenal or benign gastric ulcer the usual dosage regimen in 150 mg at night. Smoking is associated with a higher rate of duodenal ulcer relapse, and such patients should be advised to stop smoking. In those who fail to comply with such advice a dose of 300 mg at night provides additional therapeutic benefrt over the 150 mg dosage regimen.
Nsaid asociated peptic ulceration :acute treatment : in ulcers following non steroidal anti inflammatory drug therapy associated with continued non steroidal anti inflammatory drugs, 8 to 12 weeks treatment may be necessary with 150 mg twice daily or 300 mg at night.
Prophylaxis: For the prevention of non·steroidal anti-inflammatory drug associated duodenal ulcers Rani 150 mg
twice daily may be given ooncomitantly with non-steroidal anti·inflammatory drug therapy.
DUODENAL ULCER ASSOCIATED WITH HELlCOBACTER : PYLORI INFECTION
RANI 300 mg at bedtime or t SO mg twice daily may be given with oral amoxycinin 7SO mg three times daily and metronidazole 500 mg three times daily for two weeks. Therapy with RANI only should continue for a further two weeks. This dose regimen Significantly reduces the frequency of duodenal ulcer recurrence.
POST -OPERATIVE ULCER: The standard dosage reqlmen for post-operative ulcer is t SO mg twice daily.
Most cases heal within four weeks. Those not fully healed after the initial four weeks usuatly do so after a further four weeks.
GASTRO-OESOPHAGEAL REFLUX DISEASE: Acute treatment: In reflux oesophagitis tSO mg twice daily or 300 mg at night is administered for up to a period of 8, or if necessary, 12 weeks. In patients with moderate to severe oesophagitis, the dosage of RANt may be increased to 150 mg four times daily for up to 12 weeks.
Symptom relief: For the relief of symptoms associated with oesophageal acid reflux, the recommended regimen is 150 mg twice daily for two weeks. This regimen may be continued for a further two weeks in those patients in whom the initial response is inadequate.
ZOLLlNGER – ELLlSON SYNDROME: The initial dosage regimen for ZoIlinger-Ellison syndrome is tSO mg three times daily, but this may be increased as necessary. Doses up to 6 g per day have been well tolerated.
CHRONIC EPISODIC DYSPEPSIA: The standard dosage regimen for patients with chronlc episod~ dyspepsia is 150 mg twice daily for up to six weeks. Anyone not responding or relapsing shortly afterwards should be investigated.
PROPHYLAXIS OF MENDELSON’S SYNDROME
150 mg 2 h before anaesthesia, and preferably 150 mg the previous evening.
PROPHYLAXIS OF HAEMORRHAGE FROM STRESS ULCERATION in seriously ill patients or prophylaxis of recurrent heamorrhage In patients bleeding from peptic ulceration: 150 mg twice daily may be substituted for the injection once oral feeding commences.
Children: The recommended oral dose for the treatment of peptic ulcer in children is 2 mglkg to 4 mglkg twice daily to a maximum of 300 mg RANI per day.
Renal impairment: Accumulation of ranitidine with resulting elevated plasma concentrations wiD occur in patients with severe renal impairment (creatinine clearance less than 50 mVmin). It is recommended that the daily dose of oral RANI in such patients should be 150 mg.
Contraindications :
RANI is contra-indicated in patients who have known hypersensitivity to any component of the preparation.
Warnings and Precautions:
The possibility of malignancy should be excluded before commencement of therapy in patients with gastric ulcer and patients of middle age and over with or recently changed dyspeptic symptoms, as treatment with RANI may mask symptoms of gastric carcinoma. Ranitidine is excreted via the kidney and so plasma levels of the drug are increased in patients with severe renal
impairment.
The dosage should be adjusted as detailed above under Dosage and Administration in Renal Impairment. Rare clinical reports suggest that ranitidine may precipitate acute porphyric attacks. RANI should therefore be avoided in patients with a history of acute porphyria. Regular supervision of patients who are takingnoo-sleroidal anti-inflammatory drugs, concomitantly with oral RANI
is recommended, especially in the elderty and in those with a history of peptic ulcer.
In patients such as the elderty, 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 relative risk increase of 1.63 % ( 95 % Cl, 1.07 – 2.48).
As RANI effervescent granules contain aspartame they should be used with caution in patients with phenylketonuria.
RANI effervescent granules contain sodium. Care should therefore be taken in treating patients in whom sodium restriction is indicated.
Interactions:
Aanitidine, at blood levels, produced by standard recommended doses, does not inhibit the hepatic cytochrome P450 -finked mixed function oxygenase system. Accordingly, RANI in usual therapeutic does not potentiate the actions of drugs, which are inactivated by this enzyme; these inctude diazepam, lignocaine, phenytoin, propranolol, theophylline and warfarin. There is no evidence of an interaction between oral ranitidine and amoxycillin and metronidazole. 1I high doses (2 g) of sucraHate are co-administered with oral ranitidine the absorption of the latter may be reduced.
This effect is not seen if sucraHate is taken after an interval of 2 h.
Pregnancy and Lactation:
Ranitidine crosses the placenta and is excreted in breast milk. Uke other drugs RANI should only be used during pregnancy or during nursing if considered essential.
Effects on Ability to Drive and Use Machines:
None reported.
Adverse Reactions :
The following convention has been utilized for the classification of undesirable effects: very common (>1/10), common (>11100, <1110), uncommon (>111000, <11100), rare (>1110,000, <111000), very rare «1110,000).
Blood & lymphatic System Disorders
Very Rare: Blood count changes (leucopenia, thrombocytopenia). These are usually reversible. Agranulocytosis or pancytopenia, sometimes with marrow hypoplasia or marrow aplasia.
Immune System Disorders : Rare : Hypersensitivity reactions (urticaria, angioneurotic oedema, fever, bronchospasm, hypotension and chest pain).
Very rare: Anaphylactic shock.
Psychiatric Disorders: Very Rare: Reversible mental confusion, depression and hallucinations. These have been reported predominantly in severely ill and elderty patients.
Nervous System Disorders
Very rare: Headache (sometimes severe), dizziness and reversible involuntary roovement disorders.
Eye Disorders: Very Rare: Reversible blurred vision.
There have been reports of blurred vision, which is suggestive of a change in accommodation.
Cardiac Disorders: Very Rare: As with other H2 receptor antagonists bradycardia, A-V block.
Vascular Disorders: Very Rare: Vasculitis.
Hepatobiliary Disorders: Rare: Transient and reversible changes in liver function lests.
Very Rare: Hepatitis (hepatocellular, hepatocanalicular or mixed) with or without jaundice), these were usually reversible.
Skin and Subcutaneous Tissue Disorders
Rare: Skin rash. Very Rare: Erythema multilorme, alopecia.
Musculoskeletal and Connective Tissue Disorders
Very Rare: Musculoskeletal symptoms such as arthralgia and myalgia.
Renal and Urinary Disorders: Very Rare: Acute interstitial nephritis.
Reproductive System and Breast Disorders : Very rare: Reversible impotence, breast symptoms in men.
Qverdosage :
Ranitidine is very specifIC in action and no particular problems are expected following overdosage with RANI. Symptomatic and supportive therapy should be given as appropriate. Clinicans should be aware of the sodium content of RANI effervescent granules.
Pharmacodynamics:
Mechanism of Action
Ranitidine is a specific, rapidly acting histamine H2-antagonist. 11 inhibits basal and stimulated secretion of gastric acid, reducing both the volume and the acid and pepsin content of the secretion.
– Pharmacodynamic Effects:
Ranitidine has a relatively long duration of action and so a single 150 mg oral dose effectively suppresses gastric acid secretion for 12 h. Clinical evidence has shown that orat ranitidine combined with amoxycillin and metronidazole eradicates Helicobacter pylori in approximately 90% of patients. This combination therapy has been shown 10 significanlly reduce duodenal ulcer recurrence. Helicobacter pylori infects about 95% of patients with duodenal ulcer and 80% of patients with gastric ulcer. THIS MEDICAMENT is a 0ClJcI
Pharmacokinetics : Absorption :
The bioavailability of oral ranitidine is wtW::fl aflecls your health ~ its conSistently about 50%. Peak concentrations in pla~a, ~rmally in the range 300 const.mpIioncontrarytoilstructions to 550 nanograms/mL occur 2 10 3 h after oral administration of a 150 rng dose. is dangerous IOf you. Concentrations of ranitidine in plasma are proportional to oral dose up to and FokIw. . strdty the doctor’s
including 300 mg
Metabolism :
Ranitidine is not extensively metabolized. The metabolism of the instructions ~ the pharmacist ranitidine is similar after both oral and i.v. dosing: about 6 % of the dose being excreted in urine as theNoxlde, 2 % of the S-oxide, 2% as desmethylranitidine are the experts in medicines, their and 1 to 2 % as the furolc acid analogue. benefrts and risks.
Elimination:
In balance studies with 150 mg 3H-ranitidine 60% to 70% of an Do not by yourself interrupt the oral dose was excreted in urine and 26_% in faeces. Analysis of urine excreted period of treatment prescribed: . in the first 24 h after dosing showed that 35% of the oral dose were eliminated D? not repeat the same prescription
unchanged. Without consul!ing your doctor. Iiminalion of the drug is primarily by tubular secretion. The elimination half-life ~~
Packing:
A box containing 6 sachets and a pamphlet.
Storage:
Store at temperature not exceeding aooc, in a dry place.
Keep out of the reach of children.
Produced by :
Technopharma Egypl
For: Pharco Pharmaceuticals
