Ibuprom Extrasoft capsules 400 mg. №6

$28.00

Manufacturer: Poland

Symptomatic treatment of brain and dental pain, dysmenorrhea (periodic menstrual pain), neuralgia, back pain, joint pain, muscle pain, rheumatic pain, as well as cold and flu symptoms.

Category:

Description

Ibuprom Extrasoft The composition of the drug:

active substance: 1 soft capsule contains ibuprofen 400 mg;

excipients: polyethylene glycol 600, potassium hydroxide, purified water;

capsule shell: gelatin, sorbitol (E 420), purified water.

Ibuprom Extrasoft Dosage form.

The capsules are soft.

Oval gelatin transparent soft capsules of pale yellow color.

Name and location of the manufacturer.

US Pharmacy Ltd., Poland / US Pharmacia Sp. z o.o., Poland.

Street Zembitska 40, 50-507 Wroclaw, Poland / Ul. Ziebicka 40, 50-507 Wroclaw, Poland.

Name and location of the applicant.

Unilab, LP, USA.

966 Hungerford Drive, Office 3B, Rockville, MD 20850, USA / 966 Hungerford Drive, Suite 3B, Rockville, MD 20850, USA.

Pharmacotherapeutic group. Non-steroidal anti-inflammatory and anti-rheumatic drugs. Derivatives of phenylpropionic acid.

ATX code M01A E01.

Ibuprom Extrasoft Pharmacological properties.

Pharmacodynamics.

Ibuprofen is a non-steroidal anti-inflammatory drug (NSAID), a derivative of propionic acid, which has been shown to be effective in inhibiting the synthesis of prostaglandins, mediators of pain and inflammation. Ibuprofen has analgesic, antipyretic and anti-inflammatory effects.

Inside the Ibuprom Extra capsule, ibuprofen dissolved in a hydrophilic solvent is contained. After oral administration, the gelatin capsule disintegrates under the action of gastric juice, resulting in the release of already dissolved ibuprofen.

Pharmacokinetics.

When administered orally, ibuprofen is rapidly absorbed partially in the stomach and then completely in the small intestine. After metabolism in the liver (hydroxylation, carboxylation, conjugation), pharmacologically inactive metabolites are completely excreted mainly in the urine (90%), as well as in the bile. The half-life in healthy volunteers, as well as in patients with liver and kidney disease, is 1.8-3.5 hours. Plasma protein binding is approximately 99%. At oral administration of a dosage form of usual release the maximum concentration in a blood plasma is reached in 1-2 hours. Peak plasma levels after oral administration with food are reached in 1-2 hours.

In the pharmacokinetic study, the time to peak plasma levels (Tmax) on an empty stomach for the tablet formulation was 90 minutes, while for soft capsules – 40 minutes. Thus, the analgesic effect of Ibuprom Extra occurs twice as fast as ibuprofen tablets. Ibuprofen is detected in plasma within 8 hours after taking Ibuprom Extra, soft capsules.

Indication.

Symptomatic treatment of mild to moderate pain of various origins (headache, toothache, painful menstruation), including colds and colds.

Contraindication.

Hypersensitivity to ibuprofen or to any of the components of the drug.
Hypersensitivity reactions (eg, bronchial asthma, rhinitis, angioneurotic edema, or urticaria) previously seen with ibuprofen, acetylsalicylic acid (aspirin), or other NSAIDs.
Gastric ulcer / bleeding in active form or recurrence in the anamnesis (two or more pronounced episodes of peptic ulcer disease or bleeding).
History of gastrointestinal bleeding or perforation associated with NSAID use.
Severe hepatic impairment, renal impairment, heart failure.
The last trimester of pregnancy.
Cerebrovascular or other bleeding.
Impaired hematopoiesis or blood clotting.
Severe dehydration.