Colchicine 500 mcg Tablets

Colchicine is an anti-inflammatory drug that is used to treat a variety of conditions, including gout, recurrent pericarditis, and familial Mediterranean fever.

Composition

Each Tablet Contains: Colchicine 500 mcg (active pharmaceutical ingredient). Maize Starch, Lactose Monohydrate, Talc Powder, Avicel (PH 101) and Povidone k25 (Inactive ingredients).

Pharmaceutical Form: Tablets

Indications

Colchicine tablets are an alkaloid indicated for:

Prophylaxs and Treatment of Gout Flares in adults
Familial Mediterranean fever (FMF) in adults and children 4 years or older .

Colchicine is not an analgesic medication and should not be used to treat pain from other causes.

Colchicine Dosage

Gout Flares

Prophylaxis of Gout Flares: 0.5 – 1 mg once or twice daily in adults and adolescents older than 16 years of age.
Maximum dose two tablets 0.5 mg or one tablet 1 mg per day.
Treatment of Gout Flares: 1 mg (2 tablets) at the first sign of a gout flare followed by 0.5 mg ( 1 tablet) one hour later.

FMF

Adults and Children older than 12 years 1-2 mg (2-4 tablets 0.5 mg).
Children 6 to 12 years 1-2 mg (2-4 tablets 0.5 mg),
Children 4 to 6 years 0.52 mg (1-4 tablets 0.5 mg).

Increase or decrease the dose as indicated and as tolerated in increments of 0.5 mg/day.

not to exceed the maximum recommended daily dose.

Colchicine tablets are administered orally, without regard to meals.

Colchicine FAQs

Can Colchicine be used to treat Covid?

Colchicine is not recommended for the treatment of covid infection. Colchicine has been studied for the treatment of Corona patients, due to its anti-inflammatory properties, which can contribute to alleviating the symptoms of inflammatory disease.

The studies Recommendations:

The COVID-19 treatment guidelines recommend that Colchicine should not be used to treat non-hospitalized patients with COVID-19.
It is recommended not to use Colchicine in the treatment of hospitalized patients with COVID-19 virus.

How long can you stay on Colchicine?

The duration of treatment with Colchicine tablets varies according to the type of disease to be treated. When Colchicine is used to treat Mediterranean fever, it is used for long periods, but when used to treat attacks of gout, or to prevent gout attacks, it is used for short periods.

To prevent or treat gout attacks, Colchicine is taken in low doses. Colchicine is usually prescribed with other medications that lower uric acid levels in the blood. Your doctor will tell you to stop taking Colchicine when your uric acid levels have returned to normal.

Advice: Take this medication regularly as directed by your doctor, even if you feel well. If you are taking Colchicine to prevent gout attacks, and you are taking another medicine to reduce the amount of uric acid in your body, it is likely that you will be able to stop taking Colchicine after a while. However, if you stop taking it too soon, your attacks may return or get worse.

If you are taking Colchicine to treat some other medical condition such as familial Mediterranean fever, you may need to keep taking it for the rest of your life.

Muscle Damage Warning

Colchicine causes muscle damage if used for long periods (6 months or more). Colchicine is more likely to cause muscle damage if taken with other drugs that have the same harmful effect on muscles as cholesterol medications.

Tip: Talk to your doctor before taking Colchicine if you are also taking cholesterol medications.

Colchicine to prevent or treat Gout attack

Colchicine is an anti-inflammatory drug used to control the inflammatory symptoms of the gout attack. Colchicine does not lower uric acid levels, it is only control the inflammation caused by high uric acid.

Gout is a type of arthritis. It occurs as a result of the deposition of crystals of uric acid (also called uric acid) in the joints.

But what is uric acid?… Uric acid is found naturally in the body. Some theories suggest that it may help maintain normal blood pressure in the body. The body contains uric acid that is naturally present in the body (less than 7 milligrams/dL or 420 micromoles/dL). This low percentage of uric acid remains in the blood and is not deposited in the organs. It also does not cause any inflammation or problems while in the blood.

Excessive alcohol intake, junk food, lack of exercise, weight gain, uncontrolled diabetes, etc. lead to increased levels of uric acid in the blood. Once the levels of uric acid in the blood have increased for a long time, it begins to be released from the blood and deposited in the organs.

Gout develops when uric acid deposited in the organs begins to cause inflammation. This inflammation usually affects the joints first, and this causes gout attacks. That is why gout first begins with very painful articular attacks. But later on, it affects other major organs like the heart and kidneys. If left untreated, it causes further infections and organ damage.

Gout begins with recurrent attacks of joint pain (usually in the feet first). Later, if not treated adequately, it begins to cause inflammation and damage to many joints and other organs.

Contraindications

Patients with renal or hepatic impairment should not be given Colchicine in conjunction with P-gp or strong CYP3A4 inhibitors In these patients, life-threatening and fatal Colchicine toxicity has been reported with Colchicine taken in therapeutic doses

Side Effects

Prophylaxis of Gout: The most commonly reported adverse reaction in clinical trials for the prophylaxis of gout was diarrhae.

Treatment of Gout: The most commonly reported adverse reaction in clinical trials for gout were diarrhea (23%) and pharyngoiaryngeal pain (3%).

FMF: Most common adverse reactions (up to 20%) are abdominal pain, diarrhea, nauses, and vomiting. These effects are usually mild, transient, and reversible upon lowering the dose.

Drug Interactions

Antibacterials: Increased risk of Colchicine toxicity when given with clarithromycin or erythromycin .

Cyclosporin: Possible increased risk of nephrotoxicity and myotoxicity when Colchicine given with cyclosporin (increased plasma concentration of cyclosporin).

Pregnancy & Lactation

Pregnancy Category C: There are no adequate and well-controlled studies with Colchicine in pregnant women. Colchicine crosses the human placenta.

While not studied in the treatment of gout, data from a limited number of published studies found no evidence of an increased risk of miscarriage, stillbirth, or teratogenic effects among pregnant women using Colchicine to treat familial Mediterranean fever (FMF).

Although animal reproductive and developmental studies were not conducted with Colchicine, published animal reproduction and development studies indicate that Colchicine causes embryofetal toxicity, teratogenicity, and altered postnatal development at exposures within or above the clinical therapeutic range.

Colchicine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Labor and Delivery: The effect of Colchicine on labor and delivery is unknown.

Colchicine is excreted into human milk. Limited information suggests that exclusively breast-fed infants receive less than 10 percent of the maternal weight-adjusted dose. While there are no published reports of adverse effects in breast- feeding infants of mothers taking Colchicine, Colchicine can affect gastrointestinal cell renewal and permeability.

Caution should be exercised and breast-feeding infants should be observed for adverse effects when Colchicine is adminstrated to a nursing women.

Warnings & Precautions

Fatal overdoses have been reported with Colchicine in adults and children, Keep Colchicine out of the reach of children.

Blood dyscrasias: myelosuppression, leukopenia, granulocytopenia, thrombocytopenia, and aplastic anemia have been reported.

Monitor for toxicity and if present consider temporary interruption or discontinuation of Colchicine.

Drug interaction Pigp and/or CYP3A4 inhibitors: Co-administration of Colchicine with P-gp and/or strong CYP3A4 inhibitors has resulted in life-threatening interactions and death.

Neuromuscular toxicity: Myotoxicity including rhabdomyolysis may occur, especially in combination with other drugs known to cause this effect. Consider temporary interruption or discontinuation of Colchicine.

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Product ATC: M04AC01.