Ambroxol hydrochloride/loratadine Overdose
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 hydrochloride at recommended doses and may need symptomatic treatment.
It is advisable to avoid use during the first trimester of pregnancy.
There have been very few reports of severe skin lesions eg, Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) in temporal association with the administration of expectorants eg, ambroxol hydrochloride. Mostly, these could be explained by the severity of the patient's underlying disease and concomitant medications. In addition during the early phase of SJS or TEN, a patient may first experience nonspecific influenza-like prodromes eg, fever, aching body, rhinitis, cough and sore throat.
Mislead by these nonspecific influenza-like prodromes, it is possible that a symptomatic treatment is started with a cough and cold medication. Therefore, if new skin or mucosal lesion occurs, medical advice should be sought immediately and treatment with ambroxol hydrochloride should be discontinued.
In the presence of impaired renal function, Ambroxol hydrochloride may be used only after consulting a physician.
Ambroxol hydrochloride contains 8.2 g of sorbitol per maximum recommended daily dose.
Patients with a rare hereditary condition of fructose intolerance should not take Ambroxol hydrochloride.
It also contains <1 mg of lactose. This amount does not normally cause problems in lactose intolerant patients. Nevertheless, patients with rare hereditary condition of galactose intolerance should exercise caution.
Effects on Ability to Drive or Operate Machinery: There is no evidence for an effect on 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 hydrochloride crosses the placental barrier. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development.
Extensive clinical experience after the 28th week of pregnancy has shown no evidence of harmful effects on the fetus. Nonetheless, the usual precautions regarding the use of drugs during pregnancy, should be observed. Especially during the 1st trimester, the use of Ambroxol hydrochloride is not recommended. Ambroxol hydrochloride is excreted in breast milk.
Although unfavorable effects on breastfed infants would not be expected, Ambroxol hydrochloride are not recommended for use in nursing mothers.
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include fast or irregular heartbeat; severe drowsiness or headache.
Proper storage of Loratadine:
Store Loratadine at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Do not use a tablet if the blister unit is open or torn. Use within 6 months of opening the foil pouch. Keep Loratadine out of the reach of children and away from pets.
Symptoms: Somnolence, tachycardia and headache have been reported with overdoses. A single acute ingestion of 160 mg produced no adverse effects.
Treatment: In the event of overdosage, treatment, which should be started immediately, is symptomatic and supportive.
The patients should be induced to vomit even if emesis has occurred spontaneously. Pharmacologically induced vomiting by the administration of ipecac syrup is a preferred method. However, vomiting should not be induced in patients with impaired consciousness. The action of ipecac is facilitated by physical activity and by the administration of 240-360 mL of water. If emesis does not occur within 15 min, the dose of ipecac should be repeated. Precautions against aspiration must be taken, especially in children.
Following emesis, adsorption of any drugs remaining in the stomach may be attempted by the administration of activated charcoal as a slurry with water. If vomiting is unsuccessful or contraindicated, gastric lavage should be performed. Physiologic saline solution is the lavage solution of choice, particularly in children. In adults, tap water can be used; however, as much as possible, the amount administered should be removed before the next instillation. Saline cathartics draw water into the bowel by osmosis and therefore, may be valuable for their action in rapid dilution of bowel content. Loratadine is not cleared by hemodialysis to any appreciable extent. After emergency treatment, the patient should continue to be medically monitored.
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
Some medical conditions may interact with Loratadine. 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 kidney or liver problems.
Taking Loratadine in high doses may cause drowsiness. Do NOT take more than the recommended dose without checking with your doctor.
Loratadine may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking Loratadine for a few days before the tests.
Loratadine should not be used in CHILDREN younger than 6 years old without checking with the child’s doctor; safety and effectiveness in these children have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Loratadine while you are pregnant. Loratadine is found in breast milk. If you are or will be breast-feeding while you use Loratadine, check with your doctor. Discuss any possible risks to your baby.
This is not a list of all drugs or health problems that interact with Loratadine (loratadine and pseudoephedrine).
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 Loratadine (loratadine and pseudoephedrine) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
Patients with liver disease should inform a physician before taking Loratadine.
If the patient is taking any other medicines, including medicine taken without a prescription, the patient should consult a physician before use.
Laboratory Tests: If the patient is scheduled to any skin tests for allergies, Loratadine should not be taken 2 days before the test.
Important Information About the Ingredients of Clarityn: Clarityn tablets contain lactose while Clarityn syrup contains sucrose. If the patient has an intolerance to some sugars, the pharmacist or physician should be informed before taking Clarityn.
Effects on the Ability to Drive or Operate Machinery: At the recommended dose, Loratadine is not expected to cause drowsiness or less alertness. However, very rarely, some people experiences drowsiness, which may affect ability to drive or use machinery.
Use in pregnancy & lactation: If the patient is pregnant, taking Loratadine is not recommended. If the patient is nursing, taking Loratadine is not recommended. Loratadine is excreted in breast milk. The patient should ask for advice from a pharmacist or physician before taking Loratadine.
Use in children: Do not give Loratadine to children <2 years.
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.
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Information checked by Dr. Sachin Kumar, MD Pharmacology