Consists of Ambroxol, Levocetirizine, Paracetamol, Phenylephrine
Overdose of Ambroxol (1 AL TOTAL) in details
No specific overdose symptoms have been reported in man to date.
Based on accidental overdose and/or medication error reports the observed symptoms are consistent with the known side effects of Ambroxol (1 AL TOTAL) at recommended doses and may need symptomatic treatment.
Ambroxol (1 AL TOTAL) warnings
With caution used Ambroxol (1 AL TOTAL) Lark Laboratories when tachyarrhythmia and other cardiac arrhythmias, arterial hypertension, myocarditis, heart defects, aortic stenosis, diabetes, thyrotoxicosis, glaucoma, acute heart failure (with careful medical supervision).
Increase doses or frequency of receiving albuterol (salbutamol) should be under the supervision of a doctor. Reducing the interval may be only in exceptional cases and should be strictly justified.
In the application of salbutamol there was a risk of hypokalemia, so the period of treatment in patients with severe asthma should monitor the flow levels of potassium in the blood. The risk of hypokalemia increases with hypoxia.
Ambroxol (1 AL TOTAL) precautions
Ambroxol (1 AL TOTAL) 30-mg tablets contain lactose 684 mg per maximum recommended daily dose (120 mg). Patients with rare hereditary galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take Ambroxol (1 AL TOTAL).
Ambroxol (1 AL TOTAL) liquid (30 mg/5 mL) contains sorbitol 7.4 g per maximum recommended daily dose (20 mL). Patients with rare hereditary fructose intolerance should not take Ambroxol (1 AL TOTAL).
There have been very few reports of severe skin lesions eg, Stevens-Johnson syndrome and toxic epidermal necrolysis (TEN) in temporal association with the administration of expectorants eg, ambroxol HCl. Mostly these could be explained by the severity of the patient's underlying disease and/or concomitant medication. In addition during the early phase of a Stevens-Johnson syndrome or TEN, a patient may first experience non-specific influenza-like prodromes, it is possible that a symptomatic treatment is started with a cough and cold medication.
Therefore, if new skin or mucosal lesions occur, medical advice should be sought immediately and treatment with ambroxol discontinued as a precaution.
In the presence of impaired renal function, Ambroxol (1 AL TOTAL) may be used only after consulting a physician.
Effects on the Ability to Drive or Operate Machinery: There is no evidence for an effect on the ability to drive and use machines. Studies on the effects on the ability to drive and use machines have not been performed.
Use in pregnancy & lactation: Ambroxol crosses the placental barrier. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. Extensive clinical experience after the 28th week of pregnancy has shown no evidence of harmful effects on the foetus. Nonetheless, the usual precautions regarding the use of drugs during pregnancy should be observed. Especially during the 1st trimester, the use of Ambroxol (1 AL TOTAL) is not recommended.
Ambroxol is excreted in breast milk. Therefore, Ambroxol (1 AL TOTAL) is not recommended for use in nursing mothers. However, unfavourable effects on breastfed infants would not be expected.
What happens if I overdose Levocetirizine (1 AL TOTAL)?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local, or emergency room immediately. Symptoms may include agitation; irritability; restlessness; severe drowsiness.
Proper storage of Levocetirizine (1 AL TOTAL):
Store Levocetirizine (1 AL TOTAL) between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Levocetirizine (1 AL TOTAL) out of the reach of children and away from pets.
Overdose of Levocetirizine (1 AL TOTAL) in details
Overdosage has been reported with Levocetirizine (1 AL TOTAL) dihydrochloride.
Symptoms of overdose may include drowsiness in adults and initially agitation and restlessness, followed by drowsiness in children. There is no known specific antidote to Levocetirizine (1 AL TOTAL) dihydrochloride. Should overdose occur, symptomatic or supportive treatment is recommended. Levocetirizine (1 AL TOTAL) dihydrochloride is not effectively removed by dialysis, and dialysis will be ineffective unless a dialyzable agent has been concomitantly ingested.
The acute maximal non-lethal oral dose of Levocetirizine (1 AL TOTAL) was 240 mg/kg in mice (approximately 190 times the maximum recommended daily oral dose in adults, approximately 230 times the maximum recommended daily oral dose in children 6 to 11 years of age, and approximately 180 times the maximum recommended daily oral dose in children 6 months to 5 years of age on a mg/m2 basis). In rats the maximal non-lethal oral dose was 240 mg/kg (approximately 390 times the maximum recommended daily oral dose in adults, approximately 460 times the maximum recommended daily oral dose in children 6 to 11 years of age, and approximately 370 times the maximum recommended daily oral dose in children 6 months to 5 years of age on a mg/m2 basis).
What should I avoid while taking Levocetirizine (1 AL TOTAL)?
This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.
Drinking alcohol can increase certain side effects of Levocetirizine (1 AL TOTAL).
Levocetirizine (1 AL TOTAL) warnings
Somnolence
In clinical trials the occurrence of somnolence, fatigue, and asthenia has been reported in some patients under therapy with Levocetirizine (1 AL TOTAL) dihydrochloride. Patients should be cautioned against engaging in hazardous occupations requiring complete mental alertness, and motor coordination such as operating machinery or driving a motor vehicle after ingestion of Levocetirizine (1 AL TOTAL) dihydrochloride. Concurrent use of Levocetirizine (1 AL TOTAL) dihydrochloride with alcohol or other central nervous system depressants should be avoided because additional reductions in alertness and additional impairment of central nervous system performance may occur.
Urinary Retention
Urinary retention has been reported postmarketing with Levocetirizine (1 AL TOTAL) dihydrochloride. Levocetirizine (1 AL TOTAL) dihydrochloride should be used with caution in patients with predisposing factors of urinary retention (e.g. spinal cord lesion, prostatic hyperplasia) as Levocetirizine (1 AL TOTAL) dihydrochloride may increase the risk of urinary retention. Discontinue Levocetirizine (1 AL TOTAL) dihydrochloride if urinary retention occurs.
What should I discuss with my healthcare provider before taking Levocetirizine (1 AL TOTAL)?
Some medical conditions may interact with Levocetirizine (1 AL TOTAL). Tell your doctor or pharmacist if you have any medical conditions, especially any of the following:
- 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 kidney or liver problems
- if you have trouble urinating or a condition that may increase your risk of trouble urinating (eg, enlarged prostate, spinal cord lesion)
Some MEDICINES MAY INTERACT with Levocetirizine (1 AL TOTAL). Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- Ritonavir or theophylline because they may increase the risk of Levocetirizine (1 AL TOTAL)'s side effects
This may not be a complete list of all interactions that may occur. Ask your health care provider if Levocetirizine (1 AL TOTAL) 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.
Levocetirizine (1 AL TOTAL) precautions
Alcohol: Precaution is recommended with intake of alcohol.
Risk of Urinary Retention: Caution should be taken in patients with predisposing factors of urinary retention (eg, spinal cord lesion, prostatic hyperplasia) as Levocetirizine (1 AL TOTAL) may increase the risk of urinary retention.
Lactose: Levocetirizine (1 AL TOTAL) contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take Levocetirizine (1 AL TOTAL) film-coated tablet.
Oral Solution/Drops: Methyl and Propyl Parahydroxybenzoate:
The presence of methyl and propyl parahydroxybenzoate may cause allergic reactions (possibly delayed).Oral Solution: Maltitol:
Levocetirizine (1 AL TOTAL) contains maltitol. Patients with rare hereditary problems of fructose intolerance should not take Levocetirizine (1 AL TOTAL) oral solution.Effects on the Ability to Drive or Operate Machinery: Comparative clinical trials have revealed no evidence that Levocetirizine (1 AL TOTAL) at the recommended dose impairs mental alertness, reactivity or the ability to drive.
Nevertheless, some patients could experience somnolence, fatigue and asthenia under therapy with Levocetirizine (1 AL TOTAL). Therefore, patients intending to drive, engage in potentially hazardous activities or operate machinery should take into account their response to Levocetirizine (1 AL TOTAL).
Impairment of Fertility: There are no relevant data available.
Use in Children: Even if some clinical data are available in children 6 months to 12 years, these data are not sufficient to support the administration of Levocetirizine (1 AL TOTAL) to infants and toddlers <2 years. Therefore, the administration of Levocetirizine (1 AL TOTAL) to infants and toddlers <2 years is not recommended.
Film-Coated Tablets: The use of the film-coated tablet is not recommended in children <6 years since this formulation does not allow for appropriate dose adaptation. It is recommended to use a pediatric formulation of Levocetirizine (1 AL TOTAL).
Use in Pregnancy: Caution should be exercised when prescribing to pregnant women.
For Levocetirizine (1 AL TOTAL), no clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development.
Use in Lactation: Caution should be exercised when prescribing to lactating women. Cetirizine is excreted in human milk.
What happens if I miss a dose of Levocetirizine (1 AL TOTAL)?
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.
What happens if I overdose Paracetamol (1 AL TOTAL)?
Seek emergency medical attention if you think you have used too much of this medicine.
The first signs of an Paracetamol (1 AL TOTAL) overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.
Overdose of Paracetamol (1 AL TOTAL) in details
Paracetamol (1 AL TOTAL) in massive overdosage may cause hepatic toxicity in some patients. In adults and children >12 years, hepatic toxicity may occur following ingestion of >7.5-10 g over a period of ≤8 hrs. Fatalities are infrequent (<3-4% of untreated cases) and have rarely been reported with overdoses of <15 g. In children <12 years, acute overdosage with Paracetamol (1 AL TOTAL) <150 mg/kg body weight have not been associated with hepatic toxicity. Early symptoms following a potentially hepatotoxic overdose may include: Nausea, vomiting, diaphoresis and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48-72 hrs after ingestion. In adults and children >12 years, any individual presenting with an unknown amount of Paracetamol (1 AL TOTAL) ingested or with a questionable or unreliable history about the time of ingestion should have a plasma Paracetamol (1 AL TOTAL) level drawn and be treated with N-acetylcysteine. Do not await results of assays for plasma Paracetamol (1 AL TOTAL) levels before initiating treatment with N-acetylcysteine. The following additional procedures are recommended. Promptly initiate decontamination of the stomach. A plasma Paracetamol (1 AL TOTAL) assay should be obtained as early as possible, but not sooner than 4 hrs following ingestion. Liver function studies should be obtained initially and repeated at 24-hr intervals.
Serious toxicity or fatalities have been extremely infrequent following acute overdosage in young children, possibly because of differences in the way they metabolize Paracetamol (1 AL TOTAL). In children, the maximum potential amount ingested can be more easily estimated. If >150 mg/kg or an unknown amount of Paracetamol (1 AL TOTAL) was ingested, obtain a plasma Paracetamol (1 AL TOTAL) level as soon as possible but no sooner than 4 hrs following ingestion. If an assay cannot be obtained and the estimated Paracetamol (1 AL TOTAL) ingestion exceeds 150 mg/kg, dosing with N-acetylcysteine should be initiated and continued for a full course of therapy.
What should I avoid while taking Paracetamol (1 AL TOTAL)?
Do not use any other over-the-counter cough, cold, allergy, or pain medication without first asking your doctor or pharmacist. Paracetamol (1 AL TOTAL) is contained in many combination medicines. If you use certain products together you may accidentally use too much Paracetamol (1 AL TOTAL). Read the label of any other medicine you are using to see if it contains Paracetamol (1 AL TOTAL), acetaminophen or APAP. Avoid drinking alcohol while taking this medication. Alcohol may increase your risk of liver damage while taking Paracetamol (1 AL TOTAL).
Paracetamol (1 AL TOTAL) warnings
Paracetamol (1 AL TOTAL) Sante Naturelle is used with caution in patients with hyperoxaluria, renal impairment, a history of instructions on urolithiasis. Because ascorbic acid increases iron absorption, its use in high doses can be dangerous in patients with hemochromatosis, thalassemia, polycythemia, leukemia, and sideroblastic anemia.
Patients with high content body iron should apply ascorbic acid in minimal doses.
Paracetamol (1 AL TOTAL) Sante Naturelle is used with caution in patients with deficiency of glucose-6-phosphate dehydrogenase.
The use of ascorbic acid in high doses can cause exacerbation of sickle cell anemia.
Data on the diabetogenic Paracetamol (1 AL TOTAL) of ascorbic acid are contradictory. However, prolonged use of ascorbic acid should periodically monitor your blood glucose levels.
It is believed that the use of ascorbic acid in patients with rapidly proliferating and widely disseminated tumors may worsen during the process. It should therefore be used with caution in ascorbic acid in patients with advanced cancer.
Absorption of ascorbic acid decreased while use of fresh fruit or vegetable juices, alkaline drinking.
What should I discuss with my healthcare provider before taking Paracetamol (1 AL TOTAL)?
Do not use this medication if you are allergic to acetaminophen or Paracetamol (1 AL TOTAL).
Ask a doctor or pharmacist if it is safe for you to take Paracetamol (1 AL TOTAL) if you have:
- liver disease; or
-
a history of alcoholism;
It is not known whether Paracetamol (1 AL TOTAL) will harm an unborn baby. Before using Paracetamol (1 AL TOTAL), tell your doctor if you are pregnant. This medication can pass into breast milk and may harm a nursing baby. Do not use Paracetamol (1 AL TOTAL) without telling your doctor if you are breast-feeding a baby.
Paracetamol (1 AL TOTAL) precautions
Care is advised in the administration of Paracetamol (1 AL TOTAL) to patients with severe renal or severe hepatic impairment. The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease.
Do not take more medicine than the label instructed. If the patient did not get better, talk to the physician.
Do not take anything else containing Paracetamol (1 AL TOTAL) while taking Paracetamol (1 AL TOTAL).
Inform the physician at once if the patient take too much of Paracetamol (1 AL TOTAL), even if the patient feel well. This is because too much Paracetamol (1 AL TOTAL) can cause delayed, serious liver damage.
Patients should be advised that Paracetamol (1 AL TOTAL) may cause severe skin reactions. If a skin reaction eg, skin reddening, blisters or rash occurs, they should stop use and seek medical assistance right away.
Use in pregnancy & lactation: Epidemiological studies in human pregnancy have shown no ill effects due to Paracetamol (1 AL TOTAL) used in the recommended dosage, but patients should follow the advice of the physician regarding its use. Paracetamol (1 AL TOTAL) is excreted in breast milk but not in a clinically significant amount. Available published data do not contraindicate breastfeeding.
What happens if I miss a dose of Paracetamol (1 AL TOTAL)?
Since Paracetamol (1 AL TOTAL) is often used only when needed, you may not be on a dosing schedule. If you are using the medication regularly, use the missed dose as soon as you remember. If it is almost time for your next regularly scheduled dose, skip the missed dose and use your next dose as directed. Do not use extra medicine to make up for a missed dose.
What happens if I overdose Phenylephrine (1 AL TOTAL)?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local, or emergency room right away. Symptoms may include confusion; hallucinations; irregular or unusually slow or rapid heartbeat; rapid breathing; seizures.
Proper storage of Phenylephrine (1 AL TOTAL):
Store Phenylephrine (1 AL TOTAL) 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 Phenylephrine (1 AL TOTAL) out of the reach of children and away from pets.
Overdose of Phenylephrine (1 AL TOTAL) in details
Overdose of Phenylephrine (1 AL TOTAL) (phenylephrine hydrochloride) can cause a rapid rise in blood pressure. Symptoms of overdose include headache, vomiting, hypertension, reflex bradycardia, a sensation of fullness in the head, tingling of the extremities, and cardiac arrhythmias including ventricular extrasystoles and ventricular tachycardia.
What should I avoid while taking Phenylephrine (1 AL TOTAL)?
Do not take phenylephrine rectal rectal suppository by mouth. It is for use only in your rectum.
Ask a doctor or pharmacist before taking any cough, cold, or allergy medicine. Phenylephrine is contained in many combination medicines. Taking certain products together can cause you to get too much phenylephrine. Check the label to see if a medicine contains phenylephrine, or a decongestant.
Phenylephrine (1 AL TOTAL) warnings
Exacerbation of Angina, Heart Failure, or Pulmonary Arterial Hypertension
Because of its increasing blood pressure effects, Phenylephrine (1 AL TOTAL) can precipitate angina in patients with severe arteriosclerosis or history of angina, exacerbate underlying heart failure, and increase pulmonary arterial pressure.
Peripheral and Visceral Ischemia
Phenylephrine (1 AL TOTAL) can cause excessive peripheral and visceral vasoconstriction and ischemia to vital organs, particularly in patients with extensive peripheral vascular disease.
Skin and Subcutaneous Necrosis
Extravasation of Phenylephrine (1 AL TOTAL) can cause necrosis or sloughing of tissue. Avoid extravasation by checking infusion site for free flow.
Bradycardia
Phenylephrine (1 AL TOTAL) can cause severe bradycardia and decreased cardiac output.
Renal Toxicity
Phenylephrine (1 AL TOTAL) can increase the need for renal replacement therapy in patients with septic shock. Monitor renal function.
Risk of Augmented Pressor Affect in Patients with Autonomic Dysfunction
The increasing blood pressure response to adrenergic drugs, including Phenylephrine (1 AL TOTAL), can be increased in patients with autonomic dysfunction, as may occur with spinal cord injuries.
Pressor Effect with Concomitant Oxytocic Drugs
Oxytocic drugs potentiate the increasing blood pressure effect of sympathomimetic pressor amines including Phenylephrine (1 AL TOTAL), with the potential for hemorrhagic stroke.
What should I discuss with my healthcare provider before taking Phenylephrine (1 AL TOTAL)?
- If you have an allergy to Phenylephrine (1 AL TOTAL) or any part of Phenylephrine (1 AL TOTAL).
- If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
- If you have taken certain drugs used for low mood (depression) like isocarboxazid, phenelzine, or tranylcypromine or drugs used for Parkinson's disease like selegiline or rasagiline in the last 14 days. Taking Phenylephrine (1 AL TOTAL) within 14 days of those drugs can cause very bad high blood pressure.
- If you are taking any of these drugs: Linezolid or methylene blue.
- If you have a cough with a lot of mucous.
- If you have a long-term cough caused by smoking or being around smoke, or lung problems like asthma or emphysema.
This is not a list of all drugs or health problems that interact with Phenylephrine (1 AL TOTAL).
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 Phenylephrine (1 AL TOTAL) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
Phenylephrine (1 AL TOTAL) precautions
Exacerbation of Angina, Heart Failure, or Pulmonary Arterial Hypertension
Because of its increasing blood pressure effects, Phenylephrine (1 AL TOTAL) can precipitate angina in patients with severe arteriosclerosis or history of angina, exacerbate underlying heart failure, and increase pulmonary arterial pressure.
Peripheral and Visceral Ischemia
Phenylephrine (1 AL TOTAL) can cause excessive peripheral and visceral vasoconstriction and ischemia to vital organs, particularly in patients with extensive peripheral vascular disease.
Skin and Subcutaneous Necrosis
Extravasation of Phenylephrine (1 AL TOTAL) can cause necrosis or sloughing of tissue. Avoid extravasation by checking infusion site for free flow.
Bradycardia
Phenylephrine (1 AL TOTAL) can cause severe bradycardia and decreased cardiac output.
Renal Toxicity
Phenylephrine (1 AL TOTAL) can increase the need for renal replacement therapy in patients with septic shock. Monitor renal function.
Risk of Augmented Pressor Affect in Patients with Autonomic Dysfunction
The increasing blood pressure response to adrenergic drugs, including Phenylephrine (1 AL TOTAL), can be increased in patients with autonomic dysfunction, as may occur with spinal cord injuries.
Pressor Effect with Concomitant Oxytocic Drugs
Oxytocic drugs potentiate the increasing blood pressure effect of sympathomimetic pressor amines including Phenylephrine (1 AL TOTAL), with the potential for hemorrhagic stroke.
What happens if I miss a dose of Phenylephrine (1 AL TOTAL)?
Since phenylephrine rectal is used on an as needed basis, you are not likely to miss a dose. Do not use phenylephrine rectal more than 4 times per day.
References
- DailyMed. "CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX: 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. "SODIUM CITRATE: 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. "Sodium citrate". http://www.drugbank.ca/drugs/DB09154 (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
