Salofalk (mesalazine) rectal suspension 4 g/60 g. №7 in enemas

Description

Salofalk (mesalazine) rectal suspension 4 g/60 g. №7 in enemas

Composition

active ingredient: mesalazine;

1 enema (60 g of suspension) contains 4.0 g of mesalazine (5-aminosalicylic acid);

excipients: sodium benzoate (E 211), potassium metabisulphite (E 224), disodium edetate, carbomer 934 R, potassium acetate, xanthan gum, purified water.

Dosage form

Rectal suspension.

Basic physical and chemical properties: homogeneous suspension, having a color from very light brown to brown, devoid of foreign particles.

Pharmacological group

Anti-inflammatory drugs used to treat bowel diseases.
ATX code A07E C02.

Pharmacological properties

It belongs to the category of agents acting on the foci of inflammation. Shows itself as an antioxidant.
Available in various application forms.
The drug begins to act from an hour and a half after administration or administration (depending on the form of application).
The forms of oral administration of the medication are protected by the membrane from the destructive effect, and therefore they fall as intended in the place of action – the small and large intestines.
Salofalk is not affected by factors such as pH, other medications and food intake.
The withdrawal of the drug is carried out by the kidneys.

Indications

Treatment and prevention of gastrointestinal diseases:

• Crohn’s disease (chronic inflammatory disease with nodules)
• ulcerative colitis (chronic inflammatory disease of the colon mucosa).

Contraindications

Do not use the drug in children under 2 years of age.
Allergic reactions and high sensitivity to the active substance of the drug or auxiliary components, compounds from the salicylate group.
Salofalk is unacceptable to use in the presence of severe functional disorders of the liver and kidneys, peptic ulcer of the stomach and / or duodenum.
Patients who suffer from hemorrhagic diathesis and diseases of the blood and circulatory system should also refrain from taking the drug.

Application during pregnancy and lactation

If you follow strict indications and under the supervision of a doctor, the drug can be used up to 12 weeks of pregnancy.
It is forbidden to take Salofalk one month before the expected birth, provided that the disease does not require constant intake of the drug.
Information about taking the drug during breastfeeding is not enough, therefore it is recommended to refrain from treatment with Salofalk while breastfeeding.
If you are planning a pregnancy, you should stop taking the medication or keep the dose to a minimum.

Method of administration and dosage

First of all, the dosage and duration of treatment depends on the form of release of Salofalk, the course of the disease, its severity and localization.
Salofalk in the form of rectal administration is indicated for proctitis and proctosigmoiditis. For some diseases, it is recommended to combine or combine different forms of the drug.
The average recommended dose for mild to moderate Crohn’s disease and ulcerative colitis is 500 mg three times a day. In case of complications, the dose is increased by three to four times.
The average duration of the drug is 2 to 3 months.
Salofalk enemas are used after bowel movement once at night after bowel movement.
Not prescribed for children under 6 years of age. From this age, granules are prescribed for three times a day at the rate of 30-50 mg per kilogram of weight. For prophylactic purposes, the dose is reduced by half.
Children weighing more than 40 kg can use the “adult” dose.

Overdose

Usually, there is no overdose at a controlled dose. Overdose symptoms appear the same as the side effects.

Side effects

Salofalk is well tolerated, but sometimes (extremely rarely) patients notice pain in the joints and muscles.
Individual reactions of some people can manifest themselves in the form of allergic reactions: urticaria, spasms in the bronchi, itching, myo- and pericarditis, and fever.
In some cases, problems arise with the circulatory system, the organs of the digestive tract – abdominal pain, nausea, vomiting, inflammation in the pancreas, hepatitis and others.
Dizziness and headaches are extremely rare.
Mesalazine and drugs similar in structure to it can cause systemic lupus erythematosus syndrome.