What happens if I overdose Simucin?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.
Proper storage of Simucin solution:
Store unopened vials of Simucin solution at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Simucin solution may be contaminated once opened. Store opened vials of undiluted medicine in the refrigerator between 36 and 46 degrees F (2 and 8 degrees C) for up to 4 days. Do not store in the bathroom. Keep Simucin solution out of the reach of children and away from pets.
Overdose of Simucin in details
Single intravenous doses of Simucin at 1,000 mg/kg in mice, 2,445 mg/kg in rats, 1,500 mg/kg in guinea pigs, 1,200 mg/kg in rabbits and 500 mg/kg in dogs were lethal. Symptoms of acute toxicity were ataxia, hypoactivity, labored respiration, cyanosis, loss of righting reflex and convulsions.
What should I avoid while taking Simucin?
Do not mix other medicines in a nebulizer with Simucin inhalation, unless your doctor has told you to.
Simucin warnings
Simucin AS A MUCOLYTIC AGENT
After proper administration of Simucin, an increased volume of liquefied bronchial secretions may occur. When cough is inadequate, the airway must be maintained open by mechanical suction if necessary. When there is a mechanical block due to foreign body or local accumulation, the airway should be cleared by endotracheal aspiration, with or without bronchoscopy. Asthmatics under treatment with Simucin should be watched carefully. Most patients with bronchospasm are quickly relieved by the use of a bronchodilator given by nebulization. If bronchospasm progresses, the medication should be discontinued immediately.
Simucin AS AN ANTIDOTE FOR ACETAMINOPHEN OVERDOSAGE
Generalized urticaria has been observed rarely in patients receiving oral Simucin for acetaminophen overdose. If this occurs or other allergic symptoms appear, treatment with Simucin should be discontinued unless it is deemed essential and the allergic symptoms can be otherwise controlled. If encephalopathy due to hepatic failure becomes evident, Simucin treatment should be discontinued to avoid further administration of nitrogenous substances. There are no data indicating that Simucin influences hepatic failure, but this remains a theoretical possibility.
What should I discuss with my healthcare provider before taking Simucin?
Some medical conditions may interact with Simucin solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
Some MEDICINES MAY INTERACT with Simucin solution. However, no specific interactions with Simucin solution are known at this time.
Ask your health care provider if Simucin solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Simucin precautions
Simucin AS A MUCOLYTIC AGENT
General
With the administration of Simucin, the patient may observe initially a slight disagreeable odor that is soon not noticeable. With a face mask there may be stickiness on the face after nebulization. This is easily removed by washing with water.
Under certain conditions, a color change may occur in Simucin in the opened bottle. The light purple color is the result of a chemical reaction which does not significantly affect safety or mucolytic efficacy of Simucin.
Continued nebulization of Simucin solution (n-acetyl-l-cysteine) with a dry gas will result in an increased concentration of the drug in the nebulizer because of evaporation of the solvent. Extreme concentration may impede nebulization and efficient delivery of the drug. Dilution of the nebulizing solution with appropriate amounts of Sterile Water for Injection, USP, as concentration occurs, will obviate this problem.
Simucin AS AN ANTIDOTE FOR ACETAMINOPHEN OVERDOSAGE
Occasionally severe and persistent vomiting occurs as a symptom of acute acetaminophen overdose. Treatment with oral Simucin may aggravate the vomiting. Patients at risk of gastric hemorrhage (e.g., esophageal varices, peptic ulcers, etc.) should be evaluated concerning the risk of upper gastrointestinal hemorrhage versus the risk of developing hepatic toxicity, and treatment with Simucin given accordingly. Dilution of the Simucin for
Oral Administration
) minimizes the propensity of oral Simucin to aggravate vomiting.Carcinogenesis, Mutagenesis and Impairment of Fertility
Carcinogenesis: Carcinogenicity studies in laboratory animals have not been performed with Simucin alone, nor with Simucin in combination with isoproterenol.
Long-term oral studies of Simucin alone in rats (12 months of treatment followed by 6 months of observation) at doses up to 1,000 mg/kg/day (5.2 times the human mucolytic dose) provided no evidence of oncogenic activity.
Mutagenesis: Published data1 indicate that Simucin is not mutagenic in the Ames test, both with and without metabolic activation.
Impairment of Fertility: A reproductive toxicity test to assess potential impairment of fertility was performed with Simucin (10%) combined with isoproterenol (0.05%) and administered as an aerosol into a chamber of 12.43 cubic meters. The combination was administered for 25, 30, or 35 minutes twice a day for 68 days before mating, to 200 male and 150 female rats; no adverse effects were noted in dams or pups. Females after mating were continued on treatment for the next 42 days.
Reproductive toxicity studies of Simucin in the rat given oral doses of Simucin up to 1,000 mg/kg (5.2 times the human mucolytic dose) have also been reported in the literature.1 The only adverse effect observed was a slight non-dose-related reduction in fertility at dose levels of 500 or 1,000 mg/kg/day (2.6 or 5.2 times the human mucolytic dose) in the Segment I study.
Pregnancy: Teratogenic Effects: Pregnancy Category B
Teratology: In a teratology study of Simucin in the rabbit, oral doses of 500 mg/kg/day (2.6 times the human mucolytic dose) were administered to pregnant does by intubation on days 6 through 16 of gestation. Simucin was found to be nonteratogenic under the conditions of the study.
In the rabbit, two groups (one of 14 and one of 16 pregnant females) were exposed to an aerosol of 10% Simucin and 0.05% isoproterenol hydrochloride for 30 or 35 minutes twice a day from the 16th through the 18th day of pregnancy. No teratogenic effects were observed among the offspring.
Teratology and a perinatal and postnatal toxicity study in rats were performed with a combination of Simucin and isoproterenol administered by the inhalation route. In the rat, two groups of 25 pregnant females each were exposed to the aerosol for 30 and 35 minutes, respectively, twice a day from the 6th through the 15th day of gestation. No teratogenic effects were observed among the offspring.
In the pregnant rat (30 rats per group), twice-daily exposure to an aerosol of Simucin and isoproterenol for 30 or 35 minutes from the 15th day of gestation through the 21st day postpartum was without adverse effect on dams or newborns.
Reproduction studies of Simucin with isoproterenol have been performed in rats and of Simucin alone in rabbits at doses up to 2.6 times the human dose. These have revealed no evidence of impaired fertility or harm to the fetus due to Simucin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies may not always be predictive of human responses, this drug should be used during pregnancy only if clearly needed.
Nursing Mothers
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Simucin is administered to a nursing woman.
What happens if I miss a dose of Simucin?
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.
Reviews
Consumer reviews
There are no reviews yet. Be the first to write one! |
Information checked by Dr. Sachin Kumar, MD Pharmacology
