Can I take 3 ranitidine per day

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Technical and user information (changes / additions)

Specialist information:

4.1 Areas of application:

Children (3 to 18 years):

- Short-term treatment of peptic ulcers (duodenal and benign gastric ulcers)

- Treatment of gastro-oesophageal reflux disease including reflux oesophagitis and relief of symptoms of gastro-oesophageal reflux disease

4.2 Dosage and method of application:

Dosage:

Ranitidine 150 mg:

Adults and adolescents from 12 years of age with normal kidney function:

Duodenal and benign gastric ulcers:

2 film-coated tablets ranitidine 150 mg (equivalent to 300 mg ranitidine) after dinner or before going to bed or 1 film-coated tablet each ranitidine 150 mg (equivalent to 150 mg ranitidine) in the morning and evening.
The duration of treatment is usually 4 to 8 weeks.

Relapse prevention of duodenal and benign gastric ulcers:

1 film-coated tablet ranitidine 150 mg at bedtime. The duration of treatment is up to 12 months.
Long-term therapy is indicated in patients whose medical history is known to be prone to recurrence.

Reflux esophagitis:

2 film-coated tablets ranitidine 150 mg (equivalent to 300 mg ranitidine) after dinner or before going to bed or 1 film-coated tablet each ranitidine 150 mg (equivalent to 150 mg ranitidine) in the morning and evening.
The duration of treatment is 8-12 weeks.

Zollinger-Ellison Syndrome:

At the beginning, 1 film-coated tablet ranitidine 150 mg 3 times a day (equivalent to 450 mg ranitidine / day). If necessary, the daily dose can be increased to 4-6 film-coated tablets of ranitidine 150 mg (equivalent to 600-900 mg ranitidine / day). The patient can be adjusted to higher doses should this be necessary after the gastric acid secretion has been determined (up to 6 g ranitidine / day have been administered).

Acid aspiration prophylaxis during childbirth:

Single dose of 1 film-coated tablet ranitidine 150 mg.

Continued prophylaxis of stress-related bleeding from the stomach and duodenum:

As soon as oral food intake is possible again, 1 film-coated tablet of ranitidine 150 mg (equivalent to 300 mg ranitidine / day) should be taken twice a day for the further duration of the risk.

To brush:

Children over 2 years:

The daily dose is 2-4 mg / kg body weight twice a day, but no more than 300 mg ranitidine per day.
Due to their active ingredient content, the 300 mg film-coated tablets are not suitable for children.

Take up:

Children from 3 to 11 years and over 30 kg body weight
(See section 5.2 "Pharmacokinetic properties - Special populations"
Short-term treatment of peptic ulcers):

The recommended oral dose for the treatment of peptic ulcers in children is 4 mg / kg / day to 8 mg / kg / day, divided into two doses up to a maximum of 300 mg ranitidine per day (corresponding to 2 times max. ½ film-coated tablet of ranitidine 300 mg / day) for a period of 4 weeks. For patients with incomplete healing, a further 4 weeks of therapy are indicated, as healing usually occurs after 8 weeks of treatment.

Gastro-oesophageal reflux disease:

The recommended oral dose for the treatment of gastro-oesophageal reflux disease in children is 5 mg / kg / day to 10 mg / kg / day divided into two doses up to a maximum of 600 mg (corresponding to 2 times max. 1 film-coated tablet of ranitidine 300 mg / Day). The maximum dose is more likely to apply to heavier children or adolescents with severe symptoms.

Newborns:

Safety and efficacy in newborn patients are unknown.

Ranitidine 300 mg

Adults and adolescents from 12 years of age with normal kidney function:

Duodenal and benign gastric ulcers:

1 film-coated tablet of ranitidine 300 mg (equivalent to 300 mg of ranitidine) after dinner or before going to bed or ½ film-coated tablet of ranitidine 300 (equivalent to 150 mg of ranitidine) in the morning and in the evening.
The duration of treatment is usually 4 to 8 weeks.

Reflux esophagitis:

1 film-coated tablet of ranitidine 300 mg (equivalent to 300 mg ranitidine) after dinner or before going to bed or ½ film-coated tablet of ranitidine 300 mg (equivalent to 150 mg ranitidine) in the morning and in the evening.
The duration of treatment is 8-12 weeks.

Zollinger-Ellison Syndrome:
Start of treatment with ½ film-coated tablet ranitidine 300 mg 3 times a day (equivalent to 450 mg ranitidine / day). If necessary, the daily dose can be increased to 2–3 film-coated tablets of ranitidine 300 mg (equivalent to 600–900 mg ranitidine / day). The patient can be adjusted to higher doses should this be necessary after the gastric acid secretion has been determined (up to 6 g ranitidine / day have been administered).

To brush:

Children over 2 years:

The daily dose is 2-4 mg / kg body weight twice a day, but no more than 300 mg ranitidine per day.
Due to their active ingredient content, the 300 mg film-coated tablets are not suitable for children.

Take up:

Children from 3 to 11 years and over 30 kg body weight
(See section 5.2 "Pharmacokinetic properties - Special populations"
Short-term treatment of peptic ulcers):

The recommended oral dose for the treatment of peptic ulcers in children is 4 mg / kg / day to 8 mg / kg / day, divided into two doses up to a maximum of 300 mg ranitidine per day (corresponding to 2 times max. ½ film-coated tablet of ranitidine 300 mg / day) for a period of 4 weeks. For patients with incomplete healing, a further 4 weeks of therapy are indicated, as healing usually occurs after 8 weeks of treatment.

Gastro-oesophageal reflux disease:

The recommended oral dose for the treatment of gastro-oesophageal reflux disease in children is 5 mg / kg / day to 10 mg / kg / day divided into two doses up to a maximum of 600 mg (corresponding to 2 times max. 1 film-coated tablet of ranitidine 300 mg / Day). The maximum dose is more likely to apply to heavier children or adolescents with severe symptoms.

Newborns:

Safety and efficacy in newborn patients are unknown.

4.4 Special warnings and precautions for use:

Children and adolescents:

Children under 3 years of age and weighing less than 30 kg should be excluded from treatment as long as there is insufficient experience (see section 4.2)

Delete: Ranitidine is not recommended for children under 2 years of age.

4.8 Side effects:

Children and adolescents:

The safety of ranitidine has been studied in children 0-16 years of age with acid-related disorders. Ranitidine was generally well tolerated and the side effect profile was similar to that in adults. There is limited data on long-term safety, particularly on growth and development.

5.2 Pharmacokinetic properties:

Special patient groups:

Children (3 years and older):

A limited amount of pharmacokinetic data has shown that there are no significant differences in half-life (for children 3 years and older: 1.7-2.2 h) and plasma clearance (for children 3 years and older: 9- 22 ml / min / kg) between children and healthy adults receiving ranitidine when adjusted for body weight.

PARRanitidine

Link to Ranitidine PAR

Status 04/11/2014

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