Viartril-S 1500mg Rottapharm's oral powder reduces mild and moderate osteoarthritis symptoms (30 packs)

Dosage form Powder mixed oral solution
Specifications 30 package box
Ingredient Glucosamine sulfate

Ingredient

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Composition information	Content
Glucosamine sulfate	1500mg

Uses

indications

viartril s package is indicated in the following cases:

Symptoms of mild and medium knee osteoarthritis.

Pharmacokology

The main active ingredient Glucosamine Sulfate is the salt of glucosamine amino-Saccharide, present as normal physiological substances in the human body and is used in combination with sulfate roots to biosynthesis hyaluronic acid of the solution and glycosaminoglycan of the cartilage substrate. Therefore, the mechanism of action of glucosamine sulfate is to stimulate the synthesis of glycosaminoglycan and protooglycan of the joint.Moreover, Glucosamine has anti-inflammatory and inhibited effects of degeneration of articular cartilage mainly due to Interleukin 1 inhibition (IL-1), may be due to the metabolic activity of glucosamine, on the one hand, which is effective on symptoms of osteoarthritis, on the other hand can slow down the structural damage of the joints that have been proved in long-term clinical studies.

pharmacokinetics

Human and animal studies have shown that after taking Glucosamine marking 14C, this substance is absorbed and distributed in the body. In people about 90% of the doses of the markers are absorbed. Glucosamine absolute bioavailability in mice after taking Glucosamine sulfate is 26%, due to the first metabolism. The absolute bioavailability of the person has not been known, but the correlation calculations suggested that the absolute bioavailability of the person is similar to that of the mouse, in other words, it is from 20 to 30%.

After healthy volunteers drink glucosamine cartilage in a stable state (C Max, SS) is 1602+425 ng/ml (8.9 AM). This concentration reaches after 1.5 to 4 hours (average: 3 hours) after use (TMAX). In a stable state, the AUC of the drug concentration in plasma over time is 145644 ± 4138 ng/ml. These parameters obtained when the stomach is empty and it is still unknown whether the food changes this significant absorption of the drug.

If after oral absorption, Glucosamine significantly distributed in the outer chamber (including the activated substance: see below) with the apparent distribution volume 37 times the total amount of water in the human body. Glucosamine's protein bonds are still unknown. The metabolic properties of glucosamine have not been studied and this drug is a natural substance present in the human body used in biosynthesis of some components in articular cartilage.

In humans, glucosamine's last waste duration of plasma is estimated by glucosamine concentration in plasma, which can be determined after more than 48 hours after drinking. The measured value is about 15 hours.

In humans, after taking Glucosamine marking 14C, the excretion through the urine of this radioactive marker is 10 ± 9% of the treatment dose during excretion through 13 ± 0.1%. The excretion through the urine of glucosamine does not change average in humans after drinking is low (about 1% of the dose of treatment). These results show that the kidneys play a significant role in the elimination of glucosamine and/or of its metabolites and/or its divestment products.

Glucosamine pharmacokinetics are indicated as linear after use once a day in the dose of 700 - 1500 mg, while at the dose of 3000 mg of glucosamine in plasma concentrations lower than expected to increase the dose. The pharmacokinetics of glucosamine in a stable state regardless of time, indicating that there is no accumulation or bioavailability when compared to the pharmacokinetic characteristics observed when treating single therapy. Glucosamine pharmacokinetics in men and women are similar and there is no clear difference between healthy volunteers and patients with knee osteoarthritis. After that, the average plasma concentration of glucosamine at 3 hours after treatment of the dose of 1500 mg was repeated once a day was 7.2 µm, similar to the defined concentration at a healthy volunteer, while the average concentration in the activated substance was only 25% lower and thus the concentration was in the range of 10 µm.The pharmacokinetics of glucosamine have not been studied in patients with liver or kidney failure due to consideration of the safety of the drug and due to the limited role of the kidneys in glucosamine excretion so there is no recommendation to reduce the dose in these objects.

The concentration of glucosamine in plasma and in the activated substance in a stable state after the treatment is repeated once a day at a dose of 1500 mg in the range of 10 µm and therefore suitable for pharmacological concentrations in experimental animal models proving the mechanism of action and clinical effects of the drug.

Before taking Viartril-S 1500mg Rottapharm's oral powder reduces mild and moderate osteoarthritis symptoms (30 packs)

How to use

Take oral use.

Dosage

for people over 18 years old:

1 pack of viartril-S 1500 mg oral once a day.

Can be used for solitary glucosamine sulfate or in combination with other drugs such as chondroitin 1200mg/day.

Time to use the drug depending on the individual, at least use continuously for 2 to 3 months to ensure the effectiveness of treatment.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.What do

do when overdose? Based on the studies of acute and chronic toxic toxicity on animals, the irregular poisoning symptoms occur when the dose is 200 doses of treatment. However, if an overdose occurs, symptomatic treatment should be applied and should apply standard support measures if necessary, such as restoring electrolytes.

What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned.

Side Effects

When using viartril s package, you may experience unwanted effects (ADR).

Clinical trials on Viartril®-S show this drug well tolerated. Side effects are perceived on a low patient rate. Side effects are often temporary, mild, and can be broken down according to the frequency of the following:

Common (ADR> 1/100 patients):

Stomach disorders: abdominal pain, nausea, flatulence, constipation, diarrhea or indigestion.

Nervous system disorders: headache, sleep, fatigue.

Uncommon (1/100> ADR> 1/1000 patients):

Skin and subcutaneous disorders: Red rash, rashes, skin rash.

Side effects do not know the frequency of meeting:

Allergic reactions, dizziness, vision disorders, hair loss.

Instructions on how to handle ADR

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

viartril s package in the following cases:

Pregnant women, nursing women, children, minors under 18 years of age because there is no data on safety and effectiveness.

Hypersensitivity to glucosamine or any ingredients of the drug.

Patient allergies to crab shrimp shells due to the main ingredient in crab shells.

Be cautious when using

Doctors must be advised to eliminate joint diseases that other treatments should be considered. Be careful when treating patients with impaired glucose tolerance. Controlling more intense blood sugar levels may be essential for diabetics at the beginning of treatment.

In asthma patients, Viartril®-S should be carefully used because these patients may experience more allergic reactions to glucosamine, which can increase the ability of the disease. The sodium content in oral preparation (151 mg in the dose of 1500 mg daily) should be considered when using the drug for patients who need to control the diet with sodium.

No special studies are conducted in patients with liver or kidney failure. The characteristics of the dynamic and toxicity of the drug do not indicate the limitations when used in these patients. However, the treatment for patients with severe liver or kidney failure should be strictly controlled.

Patients with allergies on some types of sugar should consult a doctor before taking the drug.

Caution for patients with phenylketonuria due to the powder of oral solution containing aspartame.

Caution for patients with non -tolerance fructose due to the powder of oral solution containing sorbitol.

Caution for patients with galactose intolerance, lactase-deficiency or glucose-galactose malabsorption due to lactose capsules.

The ability to drive and operate machinery

has not seen any drugs that affect the ability to drive and operate machinery. However, there is no research on the effects of drugs on driving and operating machinery, recommending the medication carefully if the patient has a headache, sleeping, fatigue, dizziness or vision disorders.

Pregnancy

There is no full study of the use of glucosamine in pregnant women. It is not recommended to use glucosamine for pregnant women.

Breastfeeding period

It is unclear whether glucosamine is excreted in breast milk or not. It is not recommended to use glucosamine for nursing women.

Drug interaction

There has been no specific research on drug interactions conducted. However, the physical and chemical properties of glucosamine sulfate suggested that there is no significant interaction.

However, there is a report that Cumarinic's anticoagulant effect increases when treatment in combination with glucosamine sulfate. Therefore, it is advisable to control more coagulation parameters in these patients when starting or ending with glucosamine treatment.

Treatment of oral glucosamine sulfate can increase tetracycline absorption in the stomach. Pain or anti -inflammatory drugs or non -steroids can be treated with glucosamine sulfate.

Storage

Store at a temperature not exceeding 30 ° C.

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