What happens if I overdose Speedcet?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.
Proper storage of Speedcet:
Store Speedcet at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Speedcet out of the reach of children and away from pets.
Overdose of Speedcet in details
Overdosage has been reported with Speedcet. In one adult patient who took 150 mg of Speedcet, the patient was somnolent but did not display any other clinical signs or abnormal blood chemistry or hematology results. In an 18 month old pediatric patient who took an overdose of Speedcet (approximately 180 mg), restlessness and irritability were observed initially; this was followed by drowsiness. Should overdose occur, treatment should be symptomatic or supportive, taking into account any concomitantly ingested medications. There is no known specific antidote to Speedcet. Speedcet is not effectively removed by dialysis, and dialysis will be ineffective unless a dialyzable agent has been concomitantly ingested. The acute minimal lethal oral doses were 237 mg/kg in mice (approximately 95 times the 2 maximum recommended daily oral dose in adults on a mg/m basis, or approximately 40 times the maximum recommended daily oral dose in infants on a mg/m2 basis) and 562 mg/kg in rats (approximately 460 times the maximum recommended daily oral dose in adults on a mg/m2 basis, or approximately 190 times the maximum recommended daily oral dose in infants on a mg/m2 basis). In rodents, the target of acute toxicity was the central nervous system, and the target of multiple-dose toxicity was the liver.
What should I avoid while taking Speedcet?
Tell your doctor if you regularly use other medicines that make you sleepy (such as other cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by Speedcet. Speedcet can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol. It can increase some of the side effects of Speedcet.
Speedcet warnings
Somnolence/Sedation
In clinical trials with Speedcet and Speedcet tablets, the occurrence of somnolence/sedation has been reported in some patients. Exercise due caution when driving a car or operating potentially dangerous machinery. Avoid concurrent use of Speedcet with alcohol or other CNS depressants because additional reduction in alertness and additional impairment of CNS performance may occur.
What should I discuss with my healthcare provider before taking Speedcet?
For all patients taking Speedcet (Speedcet injection):
- If you are allergic to Speedcet (Speedcet injection); any part of Speedcet (Speedcet injection); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
Children:
- If your child is younger than 6 years of age. Do not give Speedcet (Speedcet injection) to a child younger than 6 years of age.
This medicine may interact with other drugs or health problems.
Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Speedcet (Speedcet injection) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
Speedcet precautions
Activities Requiring Mental Alertness: In clinical trials, the occurrence of somnolence has been reported in some patients taking Speedcet; due caution should therefore be exercised when driving a car or operating potentially dangerous machinery. Concurrent use of Speedcet with alcohol or other CNS depressants should be avoided because additional reductions in alertness and additional impairment of CNS performance may occur.
Drug-Drug Interactions: No clinically significant drug interactions have been found with theophylline at a low dose, azithromycin, pseudoephedrine, ketoconazole, or erythromycin. There was a small decrease in the clearance of Speedcet caused by a 400 mg dose of theophylline; it is possible that larger theophylline doses could have a greater effect.
Carcinogenesis, Mutagenesis, Impairment of Fertility:
In a 2 year carcinogenicity study in rats, Speedcet was not carcinogenic at dietary doses up to 20 mg/kg (approximately 15 times the maximum recommended daily oral dose in adults on a mg/m2 basis, or approximately 7 times the maximum recommended daily oral dose in infants on a mg/m2 basis). In a 2 year carcinogenicity study in mice, Speedcet caused an increased incidence of benign liver tumors in males at a dietary dose of 16 mg/kg (approximately 6 times the maximum recommended daily oral dose in adults on a mg/m2 basis, or approximately 3 times the maximum recommended daily oral dose in infants on a mg/m2 basis). No increase in the incidence of liver tumors was observed in mice at a dietary dose of 4 mg/kg (approximately 2 times the maximum recommended daily oral dose in adults on a mg/m2 basis, or approximately equivalent to the maximum recommended daily oral dose in infants on a mg/m basis). The clinical significance of these findings during long-term use of Speedcet is not known.
Speedcet was not mutagenic in the Ames test, and not clastogenic in the human lymphocyte assay, the mouse lymphoma assay, and in vivo micronucleus test in rats.
In a fertility and general reproductive performance study in mice, Speedcet did not impair fertility at an oral dose of 64 mg/kg (approximately 25 times the maximum recommended daily oral dose in adults on a mg/m2 basis).
Pediatric Use:
The safety of Speedcet has been demonstrated in pediatric patients aged 6 to 5 years. The safety of Speedcet has been demonstrated in 168 patients aged 2 to 5 years in placebo controlled trials of up to 4 weeks duration. On a mg/kg basis, most of the 168 patients received between 0.2 and 0.4 mg/kg of Speedcet HCl. The safety of Speedcet in 399 patients aged 12 to 24 months has been demonstrated in a placebo-controlled 18 month trial, in which the average dose was 0.25 mg/kg bid, corresponding to a range of 4 to 11 mg/day. The safety of Speedcet
Oral Solution, USP has been demonstrated in 42 patients aged 6 to 11 months in a placebo-controlled 7 day trial. The prescribed dose was 0.25 mg/kg bid, which corresponded to a mean of 4.5 mg/day, with a range of 3.4 to 6.2 mg/day.
The effectiveness of Speedcet for the treatment of allergic rhinitis and chronic idiopathic urticaria in pediatric patients aged 6 months to 5 years is based on an extrapolation of the demonstrated efficacy of Speedcet in adults with these conditions and the likelihood that the disease course, pathophysiology and the drug’s effect are substantially similar between these two populations. Efficacy is extrapolated down to 6 months of age for perennial allergic rhinitis because this disease is thought to occur down to these ages in children. The recommended doses for the pediatric population are based on cross-study comparisons of the pharmacokinetics and pharmacodynamics of Speedcet in adult and pediatric subjects and on the safety profile of Speedcet in both adult and pediatric patients at doses equal to or higher than the recommended doses. The Speedcet AUC and C in pediatric subjects aged 6 to 23 months who received a mean of 2.3 mg in a single dose and in subjects aged 2 to 5 years who received a single dose of 5 mg of Speedcet
Oral Solution, was estimated to be intermediate between that observed in adults who received a single dose of 10 mg of Speedcet tablets and those who received a single dose of 20 mg of Speedcet tablets.
The safety and effectiveness of Speedcet in pediatric patients under the age of 6 months have not been established.
What happens if I miss a dose of Speedcet?
Since this medicine is taken when needed, you may not be on a dosing schedule. If you are taking the medication regularly, 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.
References
- DailyMed. "CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- DrugBank. "cetirizine". http://www.drugbank.ca/drugs/DB00341 (accessed September 17, 2018).
- MeSH. "Anti-Allergic Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
