What happens if I overdose Sofcold?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local, or emergency room immediately. Symptoms may include confusion; difficulty breathing; hallucinations; irregular or fast heartbeat; loss of consciousness; seizures; severe drowsiness; sleeplessness; tremors.
Proper storage of Sofcold:
Store Sofcold at room temperature, 68 to 77 degrees F (20 to 25 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Sofcold out of the reach of children and away from pets.
Overdose of Sofcold in details
Symptoms: Cetirizine (Sofcold): Symptoms observed after an overdose of Cetirizine (Sofcold) are mainly associated with CNS effects (sedation that appears with a single dose of 50 mg upwards) or with effects that could suggest an anticholinergic effect.
Pseudoephedrine (Sofcold): In large doses, sympathomimetics may induce a toxic psychosis with delusions and hallucinations. Some patients may develop cardiac arrhythmias, circulatory collapse, convulsions, coma, and respiratory failure, which can be lethal.
Sofcold: Acute overdosage with Sofcold may produce vomiting (Pseudoephedrine (Sofcold) only), diarrhoea, dizziness, fatigue, headache, malaise, mydriasis, urinary retention, tachycardia, arrhythmia, hypertension, signs of CNS depression (sedation, apnoea, unconsciousness, cyanosis and cardiovascular collapse) or stimulation (insomnia, hallucinations, tremor, seizures) which could be fatal.
Treatment: Treatment, preferably in hospital, should be symptomatic and supportive. Consideration should be given to the possible concomitant ingestion of other drugs. If spontaneous vomiting does not occur, it should be induced. After vomiting, the drug remaining in the stomach can be absorbed by administration of an aqueous suspension of charcoal. The usual supportive measures should be undertaken, including frequent monitoring of vital signs.
No antidote is known. Sympathomimetic amines should not be used. Hypertension and tachycardia can be controlled with use of α-blockers and/or β-blockers. Epileptic seizures can be treated with diazepam IV (or by the rectal route in children). Cetirizine (Sofcold) and Pseudoephedrine (Sofcold) are poorly eliminated by haemodialysis.
What should I avoid while taking Sofcold?
Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice. Taking a stimulant together with Pseudoephedrine (Sofcold) can increase your risk of unpleasant side effects.
Do not use any other over-the-counter cold medication without first asking your doctor or pharmacist. Pseudoephedrine (Sofcold) is contained in many medicines available over the counter. If you take certain products together you may accidentally take too much of this drug. Read the label of any other medicine you are using to see if it contains Pseudoephedrine (Sofcold).
Cetirizine (Sofcold) 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 Cetirizine (Sofcold).
Sofcold warnings
Do not use
- if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.
- if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have
- heart disease
- thyroid disease
- diabetes
- glaucoma
- high blood pressure
- trouble urinating due to an enlarged prostate gland
- liver or kidney disease. Your doctor should determine if you need a different dose.
Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.
When using this product
- do not use more than directed
- drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
Stop use and ask a doctor if
- an allergic reaction to this product occurs. Seek medical help right away.
- you get nervous, dizzy, or sleepless
- symptoms do not improve within 7 days or are accompanied by fever
If pregnant or breast-feeding:
- if breast-feeding: not recommended
- if pregnant: ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
What should I discuss with my healthcare provider before taking Sofcold?
Some medical conditions may interact with Sofcold. 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
- if you have diabetes, difficulty urinating due to an enlarged prostate, heart or kidney problems, an overactive thyroid, glaucoma, or high blood pressure
Some MEDICINES MAY INTERACT with Sofcold. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Furazolidone or MAO inhibitors (eg, phenelzine) because they can cause serious, sometimes fatal, reactions. Do not take MAO inhibitors within 2 weeks of taking Sofcold.
- Certain stimulants (albuterol, amphetamine), digitalis (eg, digoxin), or droxidopa because toxic effects on the heart may occur
- Urinary alkalinizers (eg, sodium bicarbonate) because it may increase the actions and side effects of Sofcold
- Bromocriptine or certain antihypertensives (guanethidine, methyldopa, mecamylamine, reserpine) because their effectiveness may be decreased by Sofcold
This may not be a complete list of all interactions that may occur. Ask your health care provider if Sofcold 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.
Sofcold precautions
Due to its Pseudoephedrine (Sofcold) component, Sofcold (Cetirizine (Sofcold), Pseudoephedrine (Sofcold)) Tablets should be used with caution in patients with hypertension, diabetes mellitus, ischemic heart disease, increased intraocular pressure, hyperthyroidism, renal impairment, or prostatic hypertrophy. Patients with decreased renal function should be given a lower initial dose (one tablet per day) because they have reduced elimination of Cetirizine (Sofcold) and Pseudoephedrine (Sofcold).
Activities Requiring Mental Alertness
In clinical trials, the occurrence of somnolence has been reported in some patients taking Cetirizine (Sofcold) or Sofcold (Cetirizine (Sofcold), Pseudoephedrine (Sofcold)) Tablets; due caution should therefore be exercised when driving a car or operating potentially dangerous machinery after taking Sofcold (Cetirizine (Sofcold), Pseudoephedrine (Sofcold)) Tablets. Concurrent use of Sofcold (Cetirizine (Sofcold), Pseudoephedrine (Sofcold)) Tablets with alcohol or other CNS depressants should be avoided because additional reductions in alertness and additional impairment of CNS performance may occur.
Carcinogenesis, Mutagenesis and Impairment of Fertility
There are no carcinogenicity trials of Pseudoephedrine (Sofcold) and Cetirizine (Sofcold) in combination.
Cetirizine (Sofcold): In a 2-year study in rats, Cetirizine (Sofcold) was not carcinogenic at dietary doses up to 20 mg/kg (approximately 15 times the maximum recommended daily dose in adults on a mg/m basis). For Cetirizine (Sofcold) administered alone, studies in dogs indicate that approximately 3% of the dose is excreted in milk, and Cetirizine (Sofcold) has been reported to be excreted in human breast milk. For Pseudoephedrine (Sofcold) administered alone, 0.4-0.7% of the dose has been reported to be excreted in human breast milk.
Because Cetirizine (Sofcold) and Pseudoephedrine (Sofcold) are excreted in milk, use of Sofcold (Cetirizine (Sofcold), Pseudoephedrine (Sofcold)) Tablets in nursing mothers is not recommended.
Geriatric Use
Clinical trials of Sofcold (Cetirizine (Sofcold), Pseudoephedrine (Sofcold)) Tablets did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients, although the elderly are more likely to have adverse reactions to sympathomimetic amines. In general, dosing in an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
The Cetirizine (Sofcold) and Pseudoephedrine (Sofcold) components of Sofcold (Cetirizine (Sofcold), Pseudoephedrine (Sofcold)) Tablets are known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
Cetirizine (Sofcold): Of the total number of subjects in clinical trials of Cetirizine (Sofcold) alone, 186 were 65 years and over, while 39 were 75 years and over. No overall differences in safety were observed between these subjects and younger subjects, and other reported experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. With regard to efficacy, clinical trials of Cetirizine (Sofcold) for each approved indication did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently than younger patients.
Pediatric Use
Sofcold (Cetirizine (Sofcold), Pseudoephedrine (Sofcold)) Tablets contain 120 mg of Pseudoephedrine (Sofcold) hydrochloride in an extended release formulation. This dose of Pseudoephedrine (Sofcold) exceeds the recommended dose for pediatric patients under 12 years of age. Therefore, clinical trials of Sofcold (Cetirizine (Sofcold), Pseudoephedrine (Sofcold)) Tablets have not been conducted in patients under 12 years of age.
What happens if I miss a dose of Sofcold?
Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.
References
- DailyMed. "PSEUDOEPHEDRINE SULFATE: 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).
- 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. "PSEUDOEPHEDRINE". http://www.drugbank.ca/drugs/DB00852 (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
