Ticlopidine hydrochloride

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Overview

What is Ticlopidine hydrochloride?

Ticlopidine hydrochloride is a platelet aggregation inhibitor. Chemically it is 5-[(2-chlorophenyl)methyl]-4,5,6,7-tetrahydrothieno [3,2-c] pyridine hydrochloride. The structural formula is:

Ticlopidine hydrochloride is a white crystalline solid. It is freely soluble in water and self-buffers to a pH of 3.6. It also dissolves freely in methanol, is sparingly soluble in methylene chloride and ethanol, slightly soluble in acetone and insoluble in a buffer solution of pH 6.3. It has a molecular weight of 300.25.

Ticlopidine HCl Tablets, USP for oral administration are provided as white to off-white, oval, unscored, film coated, imprinted tablets containing 250 mg of Ticlopidine Hydrochloride. Each tablet also contains croscarmellose sodium, microcrystalline cellulose and stearic acid as inactive ingredients. The white film coating contains hydroxypropyl methylcellulose, polyethylene glycol and titanium dioxide.

What does Ticlopidine hydrochloride look like?

What are the available doses of Ticlopidine hydrochloride?

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What should I talk to my health care provider before I take Ticlopidine hydrochloride?

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How should I use Ticlopidine hydrochloride?

Ticlopidine Hydrochloride Tablets, USP are indicated:

The recommended dose of ticlopidine hydrochloride is 250 mg bid taken with food. Other doses have not been studied in controlled trials for these indications.

What interacts with Ticlopidine hydrochloride?

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What are the warnings of Ticlopidine hydrochloride?

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What are the precautions of Ticlopidine hydrochloride?

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What are the side effects of Ticlopidine hydrochloride?

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What should I look out for while using Ticlopidine hydrochloride?

The use of ticlopidine hydrochloride is contraindicated in the following conditions:

What might happen if I take too much Ticlopidine hydrochloride?

One case of deliberate overdosage with ticlopidine has been reported by a foreign postmarketing surveillance program. A 38-year-old male took a single 6000-mg dose of ticlopidine (equivalent to 24 standard 250-mg tablets). The only abnormalities reported were increased bleeding time and increased SGPT. No special therapy was instituted and the patient recovered without sequelae.

Single oral doses of ticlopidine at 1600 mg/kg and 500 mg/kg were lethal to rats and mice, respectively. Symptoms of acute toxicity were GI hemorrhage, convulsions, hypothermia, dyspnea, loss of equilibrium and abnormal gait.

How should I store and handle Ticlopidine hydrochloride?

Ticlopidine Hydrochloride Tablets, USP are available for oral administration as white to off-white, oval, unscored, film coated tablets, imprinted "APO 027" on one side and plain on the other side. They are supplied as follows: Bottles of 30 (NDC 60505-0027-2)Bottles of 60 (NDC 60505-0027-4)Bottles of 500 (NDC 60505-0027-7)Bottles of 1000 (NDC 60505-0027-9)Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. APOTEX INC. Ticlopidine Hydrochloride Tablets, USP 250 mgRevised: September 2010Rev. 2Ticlopidine Hydrochloride Tablets, USP are available for oral administration as white to off-white, oval, unscored, film coated tablets, imprinted "APO 027" on one side and plain on the other side. They are supplied as follows: Bottles of 30 (NDC 60505-0027-2)Bottles of 60 (NDC 60505-0027-4)Bottles of 500 (NDC 60505-0027-7)Bottles of 1000 (NDC 60505-0027-9)Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. APOTEX INC. Ticlopidine Hydrochloride Tablets, USP 250 mgRevised: September 2010Rev. 2Ticlopidine Hydrochloride Tablets, USP are available for oral administration as white to off-white, oval, unscored, film coated tablets, imprinted "APO 027" on one side and plain on the other side. They are supplied as follows: Bottles of 30 (NDC 60505-0027-2)Bottles of 60 (NDC 60505-0027-4)Bottles of 500 (NDC 60505-0027-7)Bottles of 1000 (NDC 60505-0027-9)Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. APOTEX INC. Ticlopidine Hydrochloride Tablets, USP 250 mgRevised: September 2010Rev. 2Ticlopidine Hydrochloride Tablets, USP are available for oral administration as white to off-white, oval, unscored, film coated tablets, imprinted "APO 027" on one side and plain on the other side. They are supplied as follows: Bottles of 30 (NDC 60505-0027-2)Bottles of 60 (NDC 60505-0027-4)Bottles of 500 (NDC 60505-0027-7)Bottles of 1000 (NDC 60505-0027-9)Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. APOTEX INC. Ticlopidine Hydrochloride Tablets, USP 250 mgRevised: September 2010Rev. 2Ticlopidine Hydrochloride Tablets, USP are available for oral administration as white to off-white, oval, unscored, film coated tablets, imprinted "APO 027" on one side and plain on the other side. They are supplied as follows: Bottles of 30 (NDC 60505-0027-2)Bottles of 60 (NDC 60505-0027-4)Bottles of 500 (NDC 60505-0027-7)Bottles of 1000 (NDC 60505-0027-9)Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. APOTEX INC. Ticlopidine Hydrochloride Tablets, USP 250 mgRevised: September 2010Rev. 2Ticlopidine Hydrochloride Tablets, USP are available for oral administration as white to off-white, oval, unscored, film coated tablets, imprinted "APO 027" on one side and plain on the other side. They are supplied as follows: Bottles of 30 (NDC 60505-0027-2)Bottles of 60 (NDC 60505-0027-4)Bottles of 500 (NDC 60505-0027-7)Bottles of 1000 (NDC 60505-0027-9)Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. APOTEX INC. Ticlopidine Hydrochloride Tablets, USP 250 mgRevised: September 2010Rev. 2Ticlopidine Hydrochloride Tablets, USP are available for oral administration as white to off-white, oval, unscored, film coated tablets, imprinted "APO 027" on one side and plain on the other side. They are supplied as follows: Bottles of 30 (NDC 60505-0027-2)Bottles of 60 (NDC 60505-0027-4)Bottles of 500 (NDC 60505-0027-7)Bottles of 1000 (NDC 60505-0027-9)Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. APOTEX INC. Ticlopidine Hydrochloride Tablets, USP 250 mgRevised: September 2010Rev. 2Ticlopidine Hydrochloride Tablets, USP are available for oral administration as white to off-white, oval, unscored, film coated tablets, imprinted "APO 027" on one side and plain on the other side. They are supplied as follows: Bottles of 30 (NDC 60505-0027-2)Bottles of 60 (NDC 60505-0027-4)Bottles of 500 (NDC 60505-0027-7)Bottles of 1000 (NDC 60505-0027-9)Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. APOTEX INC. Ticlopidine Hydrochloride Tablets, USP 250 mgRevised: September 2010Rev. 2Ticlopidine Hydrochloride Tablets, USP are available for oral administration as white to off-white, oval, unscored, film coated tablets, imprinted "APO 027" on one side and plain on the other side. They are supplied as follows: Bottles of 30 (NDC 60505-0027-2)Bottles of 60 (NDC 60505-0027-4)Bottles of 500 (NDC 60505-0027-7)Bottles of 1000 (NDC 60505-0027-9)Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. APOTEX INC. Ticlopidine Hydrochloride Tablets, USP 250 mgRevised: September 2010Rev. 2

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Clinical Information

Chemical Structure

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Clinical Pharmacology

When taken orally, ticlopidine hydrochloride causes a time- and dose-dependent inhibition of both platelet aggregation and release of platelet granule constituents, as well as a prolongation of bleeding time. The intact drug has no significant activity at the concentrations attained and, although analysis of urine and plasma indicates at least 20 metabolites, no metabolite which accounts for the activity of ticlopidine has been isolated.

Ticlopidine hydrochloride, after oral ingestion, interferes with platelet membrane function by inhibiting ADP-induced platelet-fibrinogen binding and subsequent platelet-platelet interactions. The effect on platelet function is irreversible for the life of the platelet, as shown both by persistent inhibition of fibrinogen binding after washing platelets and by inhibition of platelet aggregation after resuspension of platelets in buffered medium.

Non-Clinical Toxicology

The use of ticlopidine hydrochloride is contraindicated in the following conditions:

Therapeutic doses of ticlopidine caused a 30% increase in the plasma half-life of antipyrine and may cause analogous effects on similarly metabolized drugs. Therefore, the dose of drugs metabolized by hepatic microsomal enzymes with low therapeutic ratios or being given to patients with hepatic impairment may require adjustment to maintain optimal therapeutic blood levels when starting or stopping concomitant therapy with ticlopidine. Studies of specific drug interactions yielded the following results:

Ticlopidine should be used with caution in patients who may be at risk of increased bleeding from trauma, surgery or pathological conditions. If it is desired to eliminate the antiplatelet effects of ticlopidine prior to elective surgery, the drug should be discontinued 10 to 14 days prior to surgery. Several controlled clinical studies have found increased surgical blood loss in patients undergoing surgery during treatment with ticlopidine. In TASS and CATS it was recommended that patients have ticlopidine discontinued prior to elective surgery. Several hundred patients underwent surgery during the trials, and no excessive surgical bleeding was reported.

Prolonged bleeding time is normalized within 2 hours after administration of 20 mg methylprednisolone IV. Platelet transfusions may also be used to reverse the effect of ticlopidine on bleeding. Because platelet transfusions may accelerate thrombosis in patients with TTP on ticlopidine, they should, if possible, be avoided.

Adverse reactions in stroke patients were relatively frequent with over 50% of patients reporting at least one. Most (30% to 40%) involved the gastrointestinal tract. Most adverse effects are mild, but 21% of patients discontinued therapy because of an adverse event, principally diarrhea, rash, nausea, vomiting, GI pain and neutropenia. Most adverse effects occur early in the course of treatment, but a new onset of adverse effects can occur after several months.

The incidence rates of adverse events listed in the following table were derived from multicenter, controlled clinical trials in stroke patients described above comparing ticlopidine, placebo and aspirin over study periods of up to 5.8 years. Adverse events considered by the investigator to be probably drug-related that occurred in at least 1% of patients treated with ticlopidine are shown in the following table:

Incidence of discontinuation, regardless of relationship to therapy, is shown in parentheses.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).

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