Brand Name: GELOTEK®

Generic name: Ibuprofen

Pharmaceutical category:
GELOTEK® is a nonsteroidal anti-inflammatory drug (NSAID).

Uses of:
GELOTEK® is used to relieve pain from various conditions such as headache, dental pain, menstrual cramps, muscle aches, or arthritis. It is also used to reduce fever and to relieve minor aches and pain due to the common cold or flu. GELOTEK® is a nonsteroidal anti-inflammatory drug (NSAID).

Mechanism of action:
GELOTEK® is a non-selective inhibitor of an enzyme called cyclooxygenase (COX), which is required for the synthesis of prostaglandins via the arachidonic acid pathway. COX is needed to convert arachidonic acid to prostaglandin H2 (PGH2) in the body. This PGH2 is then converted to prostaglandins. The inhibition of COX by ibuprofen therefore lowers the level of prostaglandins made by the body.
The prostaglandins that are formed from PGH2 are important mediators of sensations such as pain and processes such as fever and inflammation. The antipyretic effects may arise as a result of action on the hypothalamus leading to vasodilation, an increased peripheral blood flow and subsequent heat dissipation.
Anticoagulant effects are also mediated through inhibition of COX, which converts arachidonic acid into thromboxane A2, a vital component in platelet aggregation that leads to the formation of blood clots.
There are two forms of COX in the body – COX-1 and COX-2. The pain and inflammation reducing effects of NSAIDs are mediated through the inhibition of COX-2, while COX-1 inhibition blocks the formation of thromboxane. The long-term blockage of COX-1 with chronic use of NSAID, however, may cause gastric toxicity, as COX-1 usually maintains the gastric mucosa

After oral administration, peak serum concentration is reached after 1–2 hours and up to 99% of the drug is bound to plasma proteins. The majority of GELOTEK® is metabolised and eliminated within 24 hours in the urine, however 1% of the unchanged drug is removed through biliary excretion.

Contraindications of:
– Systemic mastocytosis
– Increased risk of bleeding due to clotting disorder
– Increased risk of bleeding
– Alcoholism
– High blood pressure
– Heart attack
– Chronic heart failure
– Stroke
– Blood clot
– Stomach or intestinal ulcer
– Liver problems
– Bleeding of the stomach or intestines
– Pregnancy
– a rupture in the wall of the stomach or intestine
– Tobacco smoking
– Increased Cardiovascular Event Risk
– Time Immediately after Coronary Bypass Surgery
– Acute thromboembolic stroke
– Chronic kidney disease stage 4 (severe)
– Chronic kidney disease stage 5 (failure)
– Kidney disease with likely reduction in kidney function
– Aspirin exacerbated respiratory disease
– History of gastric bypass surgery
– Salicylates
– NSAIDS (Non-Steroidal Anti-Inflammatory Drug)

Drug Interactions:
• Treatment of nasal congestion
• The treatment of sinus congestion and headaches caused by sinusitis.
• Temporary relief of nasal congestion and sinus
• Relieve headaches caused by sinusitis, colds, allergies, high fever
• Temporary relief of congestion associated with acute catarrh
• The treatment of otitis media and bronchitis

Taking high doses of this drug or longer should be done under medical supervision. This case must be considered about elderly, due to kidney damage possibility. Used with caution in patients wiceth peptic ulrs.
During the course of treatment with this medicine if you notice any of the following side effects of drug use and cut to see your doctor.
In case of any unusual symptoms, redness or swelling of the extremities, intensified its unrelieved pain or fever or aggravation within 10 days and sustain it for more than 3 days.

Side effects:
Each drug, along the desired treatment effects may cause some unwanted side effects. Although all of these effects cannot be seen in a person, but if you see this effects, stop medication and consult with your doctor or pharmacist.
• Itching, hives, nausea and vomiting, abdominal pain, breathing problems, fever and chills, fatigue, itching, rash, dizziness, heartburn and blood problems
• Less common side effects: seizures, hallucinations, cardiac disorders, itching, bleeding in the gastrointestinal tract, tinnitus, kidney problems, irritability, bloating, constipation, loss of appetite, diarrhea and indigestion.

400—800 mg PO 3—4 times a day. Use the lowest effective dose. Higher doses are usually necessary for RA than for OA. Doses should not exceed 3200 mg/day.
Children 1—12 years
30—40 mg/kg /day PO in 3—4 divided doses. Reduce dose to lowest effective dose. Doses exceeding 50 mg/kg/day are not recommended

Drug forms and strengths:
400mg (Rx)

GELOTEK® in the dosage of 400mg (Rx) in the pharmaceutical basket of Pars pharmed company can be presented to the market. Providing all documents related to the manufacture and analysis of this product to the Food and Drug Agency, the license and the export license was issued.