Kelo >Because of inhibitory effects of Tarontal on the proliferation and certain biosynthetic activities of fibroblasts derived from human skin, it has a potential adjuvant role for keloids, hypertrophic scars, morphea, scleroderma and other fibrosing conditions.
- Hypersensitivity to Tarontal or xanthine derivatives
- Recent retinal or cerebralhemorrhage
Effects of Drug Abuse
- No information available
- See "What Are Side Effects Associated with Using Tarontal?"
- Long-term use associated with fluid retention and hypertension
- Development of Kaposi's sarcoma associated with prolonged corticosteroid use
- See "What Are Side Effects Associated with Using Tarontal?"
- Use caution with risk factors for hemorrhage
- Discontinue at first sign of anaphylaxis
- Use with caution in renal impairment; exposure to Tarontal and/or active metabolites may increase; significance unknown
- Use with caution in the elderly due to potential for renal impairment
- Use with caution in hepatic impairment; exposure to Tarontal and/or active metabolites may increase; significance unknown
- Use Tarontal during pregnancy with caution if benefits outweigh risks
- Animal studies show risk and human studies are not available, or neither animal nor human studies were done
- Tarontal is excreted in breast milk; discontinue therapy, or do not breastfeed
Tarontal is known to inhibit the production of TNF-α, which is an important inflammatory mediator with a wide spectrum of activity, predominantly produced by mononuclear cells. Tarontal is also an active inhibitor of already formed TNF. There is also evidence that Tarontal may influence other inflammatory cytokines, such as inhibition of IL-1 and IL-6.
At the first sign of anaphylactic/anaphylactoid reaction, Tarontal must be discontinued.
Patients with chronic occlusive arterial disease of the limbs frequently show other manifestations of arteriosclerotic disease. Tarontal has been used safely for treatment of peripheral arterial disease in patients with concurrent coronary artery and cerebrovascular diseases, but there have been occasional reports of angina, hypotension, and arrhythmia. Controlled trials do not show that Tarontal causes such adverse effects more often than placebo, but, as it is a methylxanthine derivative, it is possible some individuals will experience such responses. Patients on warfarin should have more frequent monitoring of prothrombin times, while patients with other risk factors complicated by hemorrhage (e.g., recent surgery, peptic ulceration, cerebral and/or retinal bleeding) should have periodic examinations for bleeding including, hematocrit and/or hemoglobin.
In patients with hepatic or renal impairment, the exposure to Tarontal and/or active metabolites is increased. The consequences of the increase in drug exposure are not known (see Pharmacokinetics and Metabolism and DOSAGE AND ADMINISTRATION).
Tarontal should not be used in patients with recent cerebral and/or retinal hemorrhage or in patients who have previously exhibited intolerance to this product or methylxanthines such as caffeine, theophylline, and theobromine.
Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.
Tarontal is usually taken 3 times each day, with meals. Follow your doctor's instructions.
While using Tarontal, you may need frequent blood tests.
Do not crush, chew, or break an extended-release tablet. Swallow it whole.
It may take up to 4 weeks before your symptoms improve. Keep using the medicine as directed and tell your doctor if your symptoms do not improve after 8 weeks of treatment.
Store at room temperature away from moisture, heat, and light.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Overdose symptoms may include severe drowsiness, agitation, fever, flushing (warmth, redness, or tingly feeling), fainting, or seizure.
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
Copyright 1996-2019 Cerner Multum, Inc.
Latest Update: 11/9/2018, Version: 8.01
Drug-drug. Anticoagulants, nonsteroidal anti-inflammatory drugs (NSAIDs): increased risk of bleeding Antihypertensives: additive hypotension
Theobromide, theophylline: increased risk of theophylline toxicity
Drug-herbs. Anise, arnica, asafetida, chamomile, clove, dong quai, fenugreek, feverfew, garlic, ginger, ginkgo, ginseng, licorice: increased risk of bleeding
Drug-behaviors. Smoking: decreased Tarontal efficacy
PHARMACOKINETICS AND METABOLISM
After oral administration, the aqueous solution of Tarontal is almost completely absorbed. It undergoes first pass metabolism and various metabolites appear in plasma very soon after administration; peak plasma levels reach within 2 hours. The major metabolites are metabolite I and metabolite V . The plasma levels of these metabolites are respectively 5 and 8 times greater than Tarontal. Excretion is almost totally through urine, main bio transformation product being metabolite V and essentially no parent drug is found in urine. Despite variations in the levels of the parent compound and its metabolites in plasma, urinary recovery of metabolite V is consistent and dose proportional. Less than 4% of the administered dose is recovered in feces.
DOSAGE AND ADMINISTRATION
The usual dosage of Tarontal in extended-release tablet form is one tablet (400 mg) three times a day with meals.
While the effect of Tarontal may be seen within 2 to 4 weeks, it is recommended that treatment be continued for at least 8 weeks. Efficacy has been demonstrated in double-blind clinical studies of 6 months duration.
Digestive and central nervous system side effects are dose related. If patients develop these effects it is recommended that the dosage be lowered to one tablet twice a day (800 mg/day). If side effects persist at this lower dosage, the administration of Tarontal should be discontinued.
In patients with severe renal impairment (creatinine clearance below 30 mL/min) reduce dose to 400 mg once a day.
Dosing information cannot be provided for patients with hepatic impairment.
Besides its use as an adjuvant therapy in psoriasis, it has been suggested that Tarontal counteracts many of the unwanted effects of cyclosporine on red blood cells, platelets and coagulation factors. Abnormal metabolism of triglyceride is common in psoriatic patients and is exaggerated after cyclosporine therapy. Tarontal possibly reduces serum triglycerides, so it seems sensible to use Tarontal in combination with cyclosporine to reduce the side-effects of the later. Thus, Tarontal seems to be a promising well-tolerated and safe adjuvant drug for use in psoriasis.
Tarontal should be stored at room temperature between 15 C - 30 C (59 F - 86 F), in a light resistant container.