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 CYSTAGON

(Cysteamine tartrate) capsules

50 mg and 150 mg

description

CYSTAGON® (cysteamine tartrate) capsules contain cysteamine tartrate, which is a cystine depleting agent that reduces the content of cystine in the cells of patients with cystinopathy, which is an inheritance of lysosomal transport defect. CYSTAGON® (cysteamine tartrate) is the hydrogen tartrate salt of cysteamine (an amino mercaptan, β-mercaptoethylamine). Cysteine ​​bitartrate is a highly water-soluble white powder with a molecular weight of 227 and a molecular formula of C2H7NS•C4H6O6. Has the following chemical structure:

CYSTAGON® (cysteamine tartrate) structure diagram

Each CYSTAGON® (cysteamine tartrate) capsule contains 50 mg or 150 mg of cysteamine free base, such as cysteamine tartrate. CYSTAGON® (cysteamine tartrate) capsules contain the following inactive ingredients: colloidal silica, croscarmellose sodium, D&C yellow. 10 aluminum color lake water, FD&C blue. 1 aluminum lake, FD&C blue. 2 Aluminum color lake surface, FD&C red number. 40 aluminum lake, gelatin, magnesium stearate, microcrystalline cellulose, medicinal glaze, pregelatinized starch, silicon dioxide, sodium lauryl sulfate, synthetic black iron oxide and titanium dioxide

Indications

CYSTAGON® (cysteamine tartrate) is suitable for the treatment of nephrotic cystinopathy in children and adults.

Dosage and administration

In order to control nephrotic cystinopathy, cysteamine therapy should be started immediately once the diagnosis (ie, increased white blood cell cystine) is diagnosed.

New patients should start taking 1/4 to 1/6 of the maintenance dose of CYSTAGON® (cysteamine tartrate). The dose should then be gradually increased over four to six weeks to avoid intolerance.

For children under 12 years of age, the recommended maintenance dose of CYSTAGON® (cysteamine tartrate) is 1.30 g/m2/day of free alkali, taken in four divided doses. Complete CYSTAGON® (cysteamine tartrate) capsules should not be used for children under about 6 years of age because of the risk of inhalation. CYSTAGON® (cysteamine tartrate) capsules can be administered to children under about six years of age by sprinkling the contents of the capsule on food. Patients over 12 years old and weighing more than 110 pounds should receive 2.0 g/g per day in four divided doses per day.

If a dose is missed, it should be taken as soon as possible. If within two hours after the next dose, skip the missed dose and return to the regular dosing schedule. Do not double the dose.

When CYSTAGON® (cysteamine tartrate) is well tolerated, the goal of treatment is to maintain leukocyte cystine levels at 1 nmol / 1/2 five to six hours after administration of CYSTAGON® (cysteamine tartrate) Less than cysteine/mg protein. If the white blood cell cystine level is less than 2 nmol / 1/2 cystine / mg protein, patients with poor tolerance will still get significant benefits. The dose of CYSTAGON® (cysteamine tartrate) can be increased to a maximum of 1.95 g/m2/day to achieve this level. The dose of 1.95 g/m2/day is associated with an increase in the rate of withdrawal from treatment due to intolerance and an increase in the incidence of adverse events.

Patients with bladder spasm taking cysteamine hydrochloride or phosphoric cysteamine solution can be transferred to an equimolar dose of CYSTAGON® (cysteamine tartrate) capsules.

The recommended maintenance dose is 1.30 g/m2/day, which can be estimated by CYSTAGON® (cysteamine tartrate) according to the following table (considering surface area and weight).

side effect

In three clinical trials, 246 children with cystinopathy have been administered cysteamine or phosphocysteamine. Sometimes it is difficult to determine the cause and effect of side effects, because the underlying disease may cause adverse reactions.

The most common adverse reactions seen involve the gastrointestinal tract and central nervous system. These are particularly prominent at the beginning of cysteamine treatment. Temporarily discontinuing treatment and then gradually reintroducing it may be effective in improving tolerance.

Adverse reactions are not systematically collected in NCCS, but they are often listed by researchers. Therefore, the following ratios may be underestimated. The most common events (>5%) were vomiting 35%, anorexia 31%, fever 22%, diarrhea 16%, lethargy 11% and skin rash 7%.

The less common adverse events are:

Body as a whole: dehydrated.

Cardiovascular: Hypertension.

Digestive system: nausea, bad breath, abdominal pain, indigestion, constipation, gastroenteritis, duodenitis, gastrointestinal ulcers and bleeding.

Central nervous system: drowsiness, encephalopathy, headache, seizures, ataxia, confusion, tremor, hyperkinesis, hearing loss, dizziness, jitters.

Psychiatry: nervousness, abnormal thinking, depression, emotional instability, hallucinations, nightmares.

Outer skin: urticaria.

Urogenital system: interstitial nephritis, renal failure (see warning).

Clinical laboratory: abnormal liver function, anemia, leukopenia.

In the US study, 8% of patients had adverse reactions or intolerances that led to discontinuation of treatment.

Due to intolerance, drug-related vomiting, anorexia, lethargy, and fever-induced withdrawal are dose-related, and are more common in patients receiving 1.95 g/m2/day, compared to 1.30 g/m2/day.

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