Loratadine (Lexi-Drugs)

Pronunciation

(lor AT a deen)

Brand Names: US

Alavert [OTC]; Allergy Non-Drowsy [OTC]; Allergy Relief For Kids [OTC] [DSC]; Allergy Relief [OTC]; Allergy [OTC]; Childrens Loratadine [OTC]; Claritin Allergy Childrens [OTC]; Claritin Childrens [OTC]; Claritin Reditabs [OTC]; Claritin [OTC]; Loradamed [OTC]; Loratadine Childrens [OTC]; Loratadine Hives Relief [OTC] [DSC]; QlearQuil 24 Hour Relief [OTC] [DSC]; Triaminic Allerchews [OTC]

Dosing: Adult

Seasonal allergic rhinitis, urticaria: Oral: 10 mg daily once daily or 5 mg twice daily (RediTabs)

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment: Adult

No dosage adjustment provided in manufacturer’s labeling; however, the following recommendations have been recommended (Aronoff 2007):

CrCl 10-50 mL/minute: Recommended dose every 24 to 48 hours.

CrCl <10 mL/minute: Recommended dose every 48 hours.

Dialysis: Recommended dose every 48 hours.

Continuous renal replacement therapy (CRRT): No dosage adjustment necessary if clearance is 2,000 mL/minute.

Dosing: Hepatic Impairment: Adult

No dosage adjustment provided in manufacturer’s labeling; however, hepatic impairment increases systemic exposure to loratadine.

Dosing: Pediatric

Allergic symptoms/rhinitis: Oral

Children 2 to <6 years: Oral liquid or chewable tablet: 5 mg once daily

Children ≥6 years and Adolescents:

Oral liquid, capsule, tablet, or chewable tablet: 10 mg once daily

Dispersible tablet: 5 mg twice daily or 10 mg once daily

Chronic idiopathic urticaria: Limited data available (Kliegman 2011; Simons 1994):

Children 2 to 12 years: 5 mg once daily

Adolescents: 10 mg once daily

Dosing: Renal Impairment: Pediatric

There are no dosage adjustments provided in manufacturer’s labeling, however, the following recommendations have been recommended (Aronoff 2007):

Children ≥2 years and Adolescents: No dosage adjustment necessary for any degree of renal impairment.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in manufacturer’s labeling.

Use: Labeled Indications

Allergic rhinitis: Relief of nasal and non-nasal symptoms of seasonal allergic rhinitis

Urticaria: Treatment of itching due to hives (urticarial)

Clinical Practice Guidelines

Allergic Rhinitis:

AAO-HNS, “Clinical Practice Guideline: Allergic Rhinitis,” 2015

Urticaria:

EAACI/GA²LEN/EDF/WAO, “Guideline for the Definition, Classification, Diagnosis and Management of Urticaria – 2017 Update,” April 2018

Administration: Oral

May be administered without regard to meals.

Dispersible tablet: Place in mouth and allow to dissolve. Swallow with or without water.

Administration: Pediatric

Oral: Administer without regard to meals

Rapidly disintegrating tablet: Place rapidly disintegrating tablet on the tongue; tablet disintegration occurs rapidly; may administer with or without water

Dietary Considerations

May be taken without regard to meals. Some products may contain phenylalanine and/or sodium.

Storage/Stability

Store at 20°C to 25°C (68°F to 77°F).

Rapidly-disintegrating tablets: Use within 6 months of opening foil pouch, and immediately after opening individual tablet blister. Store in a dry place.

Medication Patient Education with HCAHPS Considerations

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience headache or fatigue. Have patient report immediately to prescriber severe loss of strength and energy (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

Medication Safety Issues
  Sound-alike/look-alike issues:
Contraindications

Hypersensitivity to loratadine or any component of the formulation

Warnings/Precautions

Disease-related concerns:

• Hepatic impairment: Hepatic impairment increases systemic exposure. Use with caution.

• Renal impairment: Use with caution in patients with renal impairment.

Concurrent drug therapy issues:

• Sedatives: Effects may be potentiated when used with other sedative drugs or ethanol.

Dosage form specific issues:

• Benzyl alcohol and derivatives: Some dosage forms may contain sodium benzoate/benzoic acid; benzoic acid (benzoate) is a metabolite of benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP [“Inactive” 1997]; CDC, 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors, 2001); avoid or use dosage forms containing benzyl alcohol derivative with caution in neonates. See manufacturer’s labeling.

• Phenylalanine: Some products may contain phenylalanine.

Geriatric Considerations

Loratadine is a nonsedating antihistamine. Because of its low incidence of side effects, it seems to be a good choice in the elderly; however, there is a wide variation in loratadine half-life reported in the elderly and this should be kept in mind when initiating dosing. Because of its OTC status, patients should be counseled on appropriate use.

Warnings: Additional Pediatric Considerations

Safety and efficacy for the use of cough and cold products in pediatric patients <4 years of age is limited; the AAP warns against the use of these products for respiratory illnesses in young children. Serious adverse effects including death have been reported. Many of these products contain multiple active ingredients, increasing the risk of accidental overdose when used with other products. The FDA does not recommend OTC uses for these products in pediatric patients <2 years of age and recommends to use with caution in pediatric patients ≥2 years of age. Health care providers are reminded to ask caregivers about the use of OTC cough and cold products in order to avoid exposure to multiple medications containing the same ingredient (AAP 2018; CDC 2007; FDA 2017; FDA 2018).

Pregnancy Considerations

Guidelines for the use of antihistamines in the treatment of allergic rhinitis or urticaria in pregnancy are generally the same as in nonpregnant females. Loratadine may be used when a second generation antihistamine is needed. The lowest effective dose should be used (Powell 2015; Scadding 2017; Wallace 2008; Zuberbier 2018).

Breast-Feeding Considerations

Loratadine and its active metabolite, desloratadine, are present in breast milk.

The relative infant dose (RID) of loratadine plus desloratadine has been calculated to be 1.1% when compared to a maternal dose of 40 mg/day of loratadine (Hilbert 1988).

In general, breastfeeding is considered acceptable when the RID is <10% (Anderson 2016; Ito 2000).

The RID was calculated by the authors of a study following maternal administration of a single oral dose of loratadine 40 mg to six breastfeeding women between 1 and 12 months’ postpartum. The estimated daily infant dose of loratadine equivalents via breast milk was calculated to be 29.1 mcg/day in a theoretical 4 kg infant. The half-life of loratadine in breast milk was reported to be 10.7 hours in one woman (Hilbert 1988).

Drowsiness and irritability have been reported in breastfed infants exposed to antihistamines (Ito 1993). In general, second generation antihistamines (eg, loratadine) are less sedating as compared to their first generation counterparts. If a breastfed infant is exposed to a second generation antihistamine via breast milk, they should be monitored for irritability, jitteriness, or drowsiness (Butler 2014).

When treatment with an antihistamine is needed in breastfeeding women, second generation antihistamines are preferred (Butler 2014; Powell 2015; Zuberier 2018).

Antihistamines may decrease maternal serum prolactin concentrations when administered prior to the establishment of lactation (Messinis 1985).

Lexicomp Pregnancy & Lactation, In-Depth
Briggs’ Drugs in Pregnancy & Lactation
Adverse Reactions

1% to 10%:

Central nervous system: Headache (adults: 8%), sedated state (adults: 8%), drowsiness (adults: 4%), fatigue (adults: 4%), nervousness (children: 4%)

Gastrointestinal: Xerostomia (adults: 2% to 4%), abdominal pain (children: 2%), vomiting (children: 2%), diarrhea (children: 1%)

Neuromuscular & skeletal: Hyperkinetic muscle activity (children: 3%)

Frequency not defined:

Dermatologic: Skin rash (adults)

Gastrointestinal: Gastritis (adults), nausea (adults)

Hypersensitivity: Hypersensitivity reaction (adults)

<1%, postmarketing, and/or case reports: Alopecia, anaphylaxis, cough, dizziness, dry nose, hepatic insufficiency, increased appetite, palpitations, seizure, tachycardia

Allergy and Idiosyncratic Reactions
Metabolism/Transport Effects

Substrate of CYP2D6 (minor), CYP3A4 (minor), P-glycoprotein/ABCB1; Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential

Drug Interactions 

Acetylcholinesterase Inhibitors: May diminish the therapeutic effect of Anticholinergic Agents. Anticholinergic Agents may diminish the therapeutic effect of Acetylcholinesterase Inhibitors. Risk C: Monitor therapy

Aclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination

Alcohol (Ethyl): CNS Depressants may enhance the CNS depressant effect of Alcohol (Ethyl). Risk C: Monitor therapy

Alizapride: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Amantadine: May enhance the anticholinergic effect of Anticholinergic Agents. Risk C: Monitor therapy

Amezinium: Antihistamines may enhance the stimulatory effect of Amezinium. Risk C: Monitor therapy

Amiodarone: May increase the serum concentration of Loratadine. Management: Due to reported QT interval prolongation and Torsades de Pointes with this combination, consider an alternative to loratadine when possible. Risk D: Consider therapy modification

Amphetamines: May diminish the sedative effect of Antihistamines. Risk C: Monitor therapy

Anticholinergic Agents: May enhance the adverse/toxic effect of other Anticholinergic Agents. Risk C: Monitor therapy

Azelastine (Nasal): CNS Depressants may enhance the CNS depressant effect of Azelastine (Nasal). Risk X: Avoid combination

Benzylpenicilloyl Polylysine: Antihistamines may diminish the diagnostic effect of Benzylpenicilloyl Polylysine. Management: Suspend systemic H1 antagonists for benzylpenicilloyl-polylysine skin testing and delay testing until systemic antihistaminic effects have dissipated. A histamine skin test may be used to assess persistent antihistaminic effects. Risk D: Consider therapy modification

Betahistine: Antihistamines may diminish the therapeutic effect of Betahistine. Risk C: Monitor therapy

Blonanserin: CNS Depressants may enhance the CNS depressant effect of Blonanserin. Risk D: Consider therapy modification

Botulinum Toxin-Containing Products: May enhance the anticholinergic effect of Anticholinergic Agents. Risk C: Monitor therapy

Brimonidine (Topical): May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Bromopride: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Bromperidol: May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination

Buprenorphine: CNS Depressants may enhance the CNS depressant effect of Buprenorphine. Management: Consider reduced doses of other CNS depressants, and avoiding such drugs in patients at high risk of buprenorphine overuse/self-injection. Initiate buprenorphine patches (Butrans brand) at 5 mcg/hr in adults when used with other CNS depressants.Risk D: Consider therapy modification

Cannabidiol: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Cannabis: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Chloral Betaine: May enhance the adverse/toxic effect of Anticholinergic Agents. Risk C: Monitor therapy

Chlormethiazole: May enhance the CNS depressant effect of CNS Depressants. Management: Monitor closely for evidence of excessive CNS depression. The chlormethiazole labeling states that an appropriately reduced dose should be used if such a combination must be used. Risk D: Consider therapy modification

Chlorphenesin Carbamate: May enhance the adverse/toxic effect of CNS Depressants. Risk C: Monitor therapy

Cimetropium: Anticholinergic Agents may enhance the anticholinergic effect of Cimetropium. Risk X: Avoid combination

CNS Depressants: May enhance the adverse/toxic effect of other CNS Depressants. Risk C: Monitor therapy

Dimethindene (Topical): May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Doxylamine: May enhance the CNS depressant effect of CNS Depressants. Management: The manufacturer of Diclegis (doxylamine/pyridoxine), intended for use in pregnancy, specifically states that use with other CNS depressants is not recommended. Risk C: Monitor therapy

Dronabinol: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Droperidol: May enhance the CNS depressant effect of CNS Depressants. Management: Consider dose reductions of droperidol or of other CNS agents (eg, opioids, barbiturates) with concomitant use. Exceptions to this monograph are discussed in further detail in separate drug interaction monographs. Risk D: Consider therapy modification

Eluxadoline: Anticholinergic Agents may enhance the constipating effect of Eluxadoline. Risk X: Avoid combination

Esketamine: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Flunitrazepam: CNS Depressants may enhance the CNS depressant effect of Flunitrazepam. Risk D: Consider therapy modification

Gastrointestinal Agents (Prokinetic): Anticholinergic Agents may diminish the therapeutic effect of Gastrointestinal Agents (Prokinetic). Risk C: Monitor therapy

Glucagon: Anticholinergic Agents may enhance the adverse/toxic effect of Glucagon. Specifically, the risk of gastrointestinal adverse effects may be increased. Risk C: Monitor therapy

Glycopyrrolate (Oral Inhalation): Anticholinergic Agents may enhance the anticholinergic effect of Glycopyrrolate (Oral Inhalation). Risk X: Avoid combination

Glycopyrronium (Topical): May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination

Hyaluronidase: Antihistamines may diminish the therapeutic effect of Hyaluronidase. Management: Patients receiving antihistamines (particularly at larger doses) may not experience the desired clinical response to standard doses of hyaluronidase. Larger doses of hyaluronidase may be required. Risk D: Consider therapy modification

HYDROcodone: CNS Depressants may enhance the CNS depressant effect of HYDROcodone. Management: Avoid concomitant use of hydrocodone and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug.Risk D: Consider therapy modification

HydrOXYzine: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Ipratropium (Oral Inhalation): May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination

Itopride: Anticholinergic Agents may diminish the therapeutic effect of Itopride. Risk C: Monitor therapy

Kava Kava: May enhance the adverse/toxic effect of CNS Depressants. Risk C: Monitor therapy

Levosulpiride: Anticholinergic Agents may diminish the therapeutic effect of Levosulpiride. Risk X: Avoid combination

Lofexidine: May enhance the CNS depressant effect of CNS Depressants. Management: Drugs listed as exceptions to this monograph are discussed in further detail in separate drug interaction monographs. Risk C: Monitor therapy

Lumacaftor: May decrease the serum concentration of P-glycoprotein/ABCB1 Substrates. Lumacaftor may increase the serum concentration of P-glycoprotein/ABCB1 Substrates. Risk C: Monitor therapy

Magnesium Sulfate: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Methotrimeprazine: CNS Depressants may enhance the CNS depressant effect of Methotrimeprazine. Methotrimeprazine may enhance the CNS depressant effect of CNS Depressants. Management: Reduce adult dose of CNS depressant agents by 50% with initiation of concomitant methotrimeprazine therapy. Further CNS depressant dosage adjustments should be initiated only after clinically effective methotrimeprazine dose is established. Risk D: Consider therapy modification

MetyroSINE: CNS Depressants may enhance the sedative effect of MetyroSINE. Risk C: Monitor therapy

Mianserin: May enhance the anticholinergic effect of Anticholinergic Agents. Risk C: Monitor therapy

Minocycline: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Mirabegron: Anticholinergic Agents may enhance the adverse/toxic effect of Mirabegron. Risk C: Monitor therapy

Mirtazapine: CNS Depressants may enhance the CNS depressant effect of Mirtazapine. Risk C: Monitor therapy

Nabilone: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Nitroglycerin: Anticholinergic Agents may decrease the absorption of Nitroglycerin. Specifically, anticholinergic agents may decrease the dissolution of sublingual nitroglycerin tablets, possibly impairing or slowing nitroglycerin absorption. Risk C: Monitor therapy

Opioid Agonists: CNS Depressants may enhance the CNS depressant effect of Opioid Agonists. Management: Avoid concomitant use of opioid agonists and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug.Risk D: Consider therapy modification

Orphenadrine: CNS Depressants may enhance the CNS depressant effect of Orphenadrine. Risk X: Avoid combination

Oxatomide: May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination

Oxomemazine: May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination

OxyCODONE: CNS Depressants may enhance the CNS depressant effect of OxyCODONE. Management: Avoid concomitant use of oxycodone and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Risk D: Consider therapy modification

Paraldehyde: CNS Depressants may enhance the CNS depressant effect of Paraldehyde. Risk X: Avoid combination

Perampanel: May enhance the CNS depressant effect of CNS Depressants. Management: Patients taking perampanel with any other drug that has CNS depressant activities should avoid complex and high-risk activities, particularly those such as driving that require alertness and coordination, until they have experience using the combination. Risk D: Consider therapy modification

P-glycoprotein/ABCB1 Inducers: May decrease the serum concentration of P-glycoprotein/ABCB1 Substrates. P-glycoprotein inducers may also further limit the distribution of p-glycoprotein substrates to specific cells/tissues/organs where p-glycoprotein is present in large amounts (e.g., brain, T-lymphocytes, testes, etc.). Risk C: Monitor therapy

P-glycoprotein/ABCB1 Inhibitors: May increase the serum concentration of P-glycoprotein/ABCB1 Substrates. P-glycoprotein inhibitors may also enhance the distribution of p-glycoprotein substrates to specific cells/tissues/organs where p-glycoprotein is present in large amounts (e.g., brain, T-lymphocytes, testes, etc.). Risk C: Monitor therapy

Piribedil: CNS Depressants may enhance the CNS depressant effect of Piribedil. Risk C: Monitor therapy

Pitolisant: Antihistamines may diminish the therapeutic effect of Pitolisant. Risk C: Monitor therapy

Potassium Chloride: Anticholinergic Agents may enhance the ulcerogenic effect of Potassium Chloride. Management: Patients on drugs with substantial anticholinergic effects should avoid using any solid oral dosage form of potassium chloride. Risk X: Avoid combination

Potassium Citrate: Anticholinergic Agents may enhance the ulcerogenic effect of Potassium Citrate. Risk X: Avoid combination

Pramipexole: CNS Depressants may enhance the sedative effect of Pramipexole. Risk C: Monitor therapy

Pramlintide: May enhance the anticholinergic effect of Anticholinergic Agents. These effects are specific to the GI tract. Risk D: Consider therapy modification

Ramosetron: Anticholinergic Agents may enhance the constipating effect of Ramosetron. Risk C: Monitor therapy

Ranolazine: May increase the serum concentration of P-glycoprotein/ABCB1 Substrates. Risk C: Monitor therapy

Revefenacin: Anticholinergic Agents may enhance the anticholinergic effect of Revefenacin. Risk X: Avoid combination

ROPINIRole: CNS Depressants may enhance the sedative effect of ROPINIRole. Risk C: Monitor therapy

Rotigotine: CNS Depressants may enhance the sedative effect of Rotigotine. Risk C: Monitor therapy

Rufinamide: May enhance the adverse/toxic effect of CNS Depressants. Specifically, sleepiness and dizziness may be enhanced. Risk C: Monitor therapy

Secretin: Anticholinergic Agents may diminish the therapeutic effect of Secretin. Management: Avoid concomitant use of anticholinergic agents and secretin. Discontinue anticholinergic agents at least 5 half-lives prior to administration of secretin. Risk D: Consider therapy modification

Selective Serotonin Reuptake Inhibitors: CNS Depressants may enhance the adverse/toxic effect of Selective Serotonin Reuptake Inhibitors. Specifically, the risk of psychomotor impairment may be enhanced. Risk C: Monitor therapy

Sodium Oxybate: May enhance the CNS depressant effect of CNS Depressants. Management: Consider alternatives to combined use. When combined use is needed, consider minimizing doses of one or more drugs. Use of sodium oxybate with alcohol or sedative hypnotics is contraindicated. Risk D: Consider therapy modification

Suvorexant: CNS Depressants may enhance the CNS depressant effect of Suvorexant. Management: Dose reduction of suvorexant and/or any other CNS depressant may be necessary. Use of suvorexant with alcohol is not recommended, and the use of suvorexant with any other drug to treat insomnia is not recommended. Risk D: Consider therapy modification

Tapentadol: May enhance the CNS depressant effect of CNS Depressants. Management: Avoid concomitant use of tapentadol and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Risk D: Consider therapy modification

Tetrahydrocannabinol: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Tetrahydrocannabinol and Cannabidiol: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Thalidomide: CNS Depressants may enhance the CNS depressant effect of Thalidomide. Risk X: Avoid combination

Thiazide and Thiazide-Like Diuretics: Anticholinergic Agents may increase the serum concentration of Thiazide and Thiazide-Like Diuretics. Risk C: Monitor therapy

Tiotropium: Anticholinergic Agents may enhance the anticholinergic effect of Tiotropium. Risk X: Avoid combination

Topiramate: Anticholinergic Agents may enhance the adverse/toxic effect of Topiramate. Risk C: Monitor therapy

Trimeprazine: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Umeclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination

Zolpidem: CNS Depressants may enhance the CNS depressant effect of Zolpidem. Management: Reduce the Intermezzo brand sublingual zolpidem adult dose to 1.75 mg for men who are also receiving other CNS depressants. No such dose change is recommended for women. Avoid use with other CNS depressants at bedtime; avoid use with alcohol. Risk D: Consider therapy modification

Food Interactions

Food increases bioavailability and delays peak. Management: Administer without regard to meals.

Test Interactions

May suppress the wheal and flare reactions to skin test antigens

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Capsule, Oral:

Claritin: 10 mg [contains brilliant blue fcf (fd&c blue #1)]

Generic: 10 mg

Solution, Oral:

Childrens Loratadine: 5 mg/5 mL (120 mL) [alcohol free, dye free, sugar free; contains propylene glycol, sodium benzoate; grape flavor]

Loratadine Childrens: 5 mg/5 mL (120 mL) [alcohol free, dye free, sugar free; contains polyethylene glycol, propylene glycol, sodium benzoate; grape flavor]

Loratadine Childrens: 5 mg/5 mL (120 mL [DSC]) [alcohol free, dye free, sugar free; contains propylene glycol, sodium benzoate; fruit flavor]

Loratadine Hives Relief: 5 mg/5 mL (120 mL [DSC]) [alcohol free, dye free, sugar free; contains propylene glycol, sodium benzoate; grape flavor]

Syrup, Oral:

Allergy Relief For Kids: 5 mg/5 mL (120 mL [DSC]) [contains propylene glycol, sodium benzoate]

Childrens Loratadine: 5 mg/5 mL (120 mL) [fruit flavor]

Childrens Loratadine: 5 mg/5 mL (120 mL) [alcohol free, dye free; contains propylene glycol, sodium benzoate, sodium metabisulfite; grape flavor]

Claritin: 5 mg/5 mL (60 mL [DSC], 120 mL [DSC], 150 mL [DSC]) [alcohol free, color free, dye free, sugar free; contains edetate disodium, propylene glycol, sodium benzoate; grape flavor]

Claritin Allergy Childrens: 5 mg/5 mL (240 mL) [alcohol free, dye free, sugar free; contains edetate disodium, propylene glycol, sodium benzoate, sorbitol]

Loratadine Childrens: 5 mg/5 mL (10 mL) [alcohol free, dye free, sugar free; contains propylene glycol, sodium benzoate; grape flavor]

Loratadine Childrens: 5 mg/5 mL (120 mL) [sugar free; contains polyethylene glycol, propylene glycol, sodium benzoate, sodium metabisulfite; grape flavor]

Tablet, Oral:

Alavert: 10 mg [DSC]

Allergy: 10 mg

Allergy Non-Drowsy: 10 mg

Allergy Relief: 10 mg

Allergy Relief: 10 mg [contains corn starch]

Allergy Relief: 10 mg [gluten free]

Claritin: 10 mg

Loradamed: 10 mg

QlearQuil 24 Hour Relief: 10 mg [DSC]

Generic: 10 mg

Tablet Chewable, Oral:

Claritin: 5 mg [contains aspartame, fd&c blue #2 aluminum lake; grape flavor]

Claritin Childrens: 5 mg [contains aspartame]

Loratadine Childrens: 5 mg [contains aspartame; bubble-gum flavor]

Generic: 5 mg

Tablet Disintegrating, Oral:

Alavert: 10 mg [contains aspartame]

Alavert: 10 mg [contains aspartame; citrus flavor]

Allergy: 10 mg [DSC] [contains aspartame]

Allergy Relief: 10 mg [contains aspartame; fruit flavor]

Claritin Reditabs: 5 mg, 10 mg

Triaminic Allerchews: 10 mg

Anatomic Therapeutic Chemical (ATC) Classification
  • R06AX27
Generic Available (US)

Yes

Pricing: US

Capsules (Claritin Oral)

10 mg (per each): $0.75

Capsules (Loratadine Oral)

10 mg (per each): $1.76

Chewable (Claritin Childrens Oral)

5 mg (per each): $0.80

Chewable (Claritin Oral)

5 mg (per each): $0.95

Chewable (Loratadine Oral)

5 mg (per each): $0.68

Syrup (Claritin Allergy Childrens Oral)

5 mg/5 mL (per mL): $0.07

Tablet, orally-disintegrating (Alavert Oral)

10 mg (per each): $0.43

Tablet, orally-disintegrating (Claritin Reditabs Oral)

5 mg (per each): $0.92

10 mg (per each): $0.53

Tablet, orally-disintegrating (Triaminic Allerchews Oral)

10 mg (per each): $0.64

Tablets (Claritin Oral)

10 mg (per each): $0.52

Tablets (Loratadine Oral)

10 mg (per each): $0.04 – $0.86

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer’s AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Mechanism of Action

Long-acting tricyclic antihistamine with selective peripheral histamine H1-receptor antagonistic properties

Pharmacodynamics/Kinetics

Note: The pharmacokinetic profile of children 2 to 12 years is similar to that of adults (Claritin prescribing information 2000)

Onset of action: 1-3 hours (Claritin prescribing information 2000)

Peak effect: 8-12 hours (Claritin prescribing information 2000)

Duration: >24 hours (Claritin prescribing information 2000)

Absorption: Rapid; food increases total bioavailability (AUC) by 40% to 48% (Claritin prescribing information 2000)

Distribution: Vd: 119 L/kg (Haria 1994); binds preferentially to peripheral nervous system H1 receptors; no appreciable entry into CNS (Claritin prescribing information 2000)

Protein binding: 97% to 99% (loratadine), 73% to 76% (metabolite) (Haria 1994)

Metabolism: Extensively hepatic via CYP2D6 and 3A4 to active metabolite (descarboethoxyloratadine) (Claritin prescribing information 2000)

Half-life elimination: 8.4 hours (range: 3 to 20 hours) (loratadine), 28 hours (range: 8.8 to 92 hours) (metabolite) (Claritin prescribing information 2000); hepatic impairment: 24 hours (loratadine), 37 hours (metabolite) (Claritin prescribing information 2000)

Time to peak, serum: Loratadine: 1.3 hours (loratadine), 2.3 hours (metabolite) (Claritin prescribing information 2000)

Excretion: Urine (40%) and feces (40%) as metabolites

Pharmacodynamics/Kinetics: Additional Considerations

Renal function impairment: With CrCl <30 mL/minute, AUC and Cmax are increased approximately 73% for loratadine and 120% for its metabolite.

Hepatic function impairment: AUC and Cmax doubled for loratadine

Geriatric: AUC and Cmax are increased approximately 50%, and t½ ranged from 6.7 to 37 hours

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Effects on Dental Treatment

Key adverse event(s) related to dental treatment: Xerostomia (normal salivary flow resumes upon discontinuation) and stomatitis in children (2-5 years).

Effects on Bleeding

No information available to require special precautions

Index Terms

Tavist ND

FDA Approval Date
April 12, 1993
References

Ahlfors CE. Benzyl alcohol, kernicterus, and unbound bilirubin. J Pediatr. 2001;139(2):317-319.[PubMed 11487763]

Anderson PO, Sauberan JB. Modeling drug passage into human milk. Clin Pharmacol Ther. 2016;100(1):42-52.[PubMed 27060684]

Aronoff GR, Bennett WM, Berns JS, et al. Drug Prescribing in Renal Failure: Dosing Guidelines for Adults and Children. 5th ed. Philadelphia, PA: American College of Physicians; 2007:95-168.

Butler DC, Heller MM, Murase JE. Safety of dermatologic medications in pregnancy and lactation: Part II. Lactation. J Am Acad Dermatol. 2014;70(3):417.[PubMed 24528912]

Centers for Disease Control (CDC). Neonatal deaths associated with use of benzyl alcohol—United States. MMWR Morb Mortal Wkly Rep. 1982;31(22):290-291. http://www.cdc.gov/mmwr/preview/mmwrhtml/00001109.htm[PubMed 6810084]

Claritin Reditabs (loratadine) [prescribing information]. Whitehouse Station, NJ: MSD Consumer Care Inc.; September 2014.

Claritin Syrup [package insert]. Kenilworth, NJ: Schering Corporation; July 2000.

Clissold SP, Sorkin EM, Goa KL. Loratadine: A preliminary review of its pharmacodynamic properties and therapeutic efficacy. Drugs. 1989;37(1):42-57.[PubMed 2523301]

Crumb WJ, “Loratadine Blockade of K(+) Channels in Human Heart: Comparison With Terfenadine Under Physiological Conditions,” J Pharmacol Exp Ther, 2000, 292(1):261-4.[PubMed 10604956]

Crumb WJ, “Rate-Dependent Blockade of a Potassium Current in Human Atrium by the Antihistamine Loratadine,” Br J Pharmacol, 1999, 126(3):575-80.[PubMed 10188966]

Delpon E, Valenzuela C, Gay P, et al, “Block of Human Cardiac Kv1.5 Channels by Loratadine: Voltage-, Time-, and Use-Dependent Block at Concentrations Above Therapeutic Levels,” Cardiovasc Res, 1997, 35(2):341-50.[PubMed 9349397]

Greisner WA 3rd. Onset of action for the relief of allergic rhinitis symptoms with second-generation antihistamines. Allergy Asthma Proc. 2004;25(2):81–83.[PubMed 15176489]

Haria M, Fitton A, Peters DH. Loratadine. A reappraisal of its pharmacological properties and therapeutic use in allergic disorders. Drugs. 1994; 48(4):617-637.[PubMed 7528133]

Hilbert J, Radwanski E, Affrime MB, et al, “Excretion of Loratadine in Human Breast Milk,” J Clin Pharmacol, 1988, 28(3):234-9.[PubMed 2966185]

“Inactive” ingredients in pharmaceutical products: update (subject review). American Academy of Pediatrics (AAP) Committee on Drugs. Pediatrics. 1997;99(2):268-278.[PubMed 9024461]

Ito S, Blajchman A, Stephenson M, et al. Prospective follow-up of adverse reactions in breast-fed infants exposed to maternal medication. Am J Obstet Gynecol. 1993;168(5):1393-1399.[PubMed 8498418]

Ito S. Drug therapy for breast-feeding women. N Engl J Med. 2000;343(2):118-126.[PubMed 10891521]

Lin CC, Radwanski E, Affrime M, et al, “Pharmacokinetics of Loratadine in Pediatric Subjects,” Am J Ther, 1995, 2:504-8.[PubMed 11850699]

Loradamed [package insert]. Fort Myers, FL: Medique Products; May 2007.

Luck JC and Evrard HM, “Atrial Fibrillation Associated With Loratadine Use,” J Allergy Clin Immunol, 1995, 95(2):282.

Lutsky BN, Klose P, Melon J, et al, “A Comparative Study of the Efficacy and Safety of Loratadine Syrup and Terfenadine Suspension in the Treatment of 3 to 6 Year Old Children With Seasonal Allergic Rhinitis,” Clin Ther, 1993, 15(5):855-65.[PubMed 8269452]

Messinis IE, Souvatzoglou A, Fais N, Lolis D. Histamine H1 receptor participation in the control of prolactin secretion in postpartum. J Endocrinol Invest. 1985;8(2):143-146.[PubMed 3928731]

National Heart, Lung, and Blood Institute and National Asthma Education and Prevention Program Asthma and Pregnancy Working Group, “NAEPP Expert Panel Report. Managing Asthma During Pregnancy: Recommendations for Pharmacologic Treatment – 2004 Update,” J Allergy Clin Immunol, 2005, 115(1):34-46.[PubMed 15637545]

Powell RJ, Leech SC, Till S, et al. BSACI guideline for the management of chronic urticaria and angioedema. Clin Exp Allergy. 2015;45(3):547-565.[PubMed 25711134]

Scadding GK, Kariyawasam HH, Scadding G, et al. BSACI guideline for the diagnosis and management of allergic and non-allergic rhinitis (Revised Edition 2017; First edition 2007). Clin Exp Allergy. 2017;47(7):856-889.

Simons FE, “Loratadine, a Nonsedating H1-Receptor Antagonist (Antihistamine),” Ann Allergy, 1989, 63(4):266-8.[PubMed 2572187]

Wallace DV, Dykewicz MS, Bernstein DI, et al, “The Diagnosis and Management of Rhinitis: An Updated Practice Parameter,” J Allergy Clin Immunol, 2008, 122(2 Suppl):S1-84.[PubMed 18662584]

Zuberbier T, Aberer W, Asero R, et al. The EAACI/GA²LEN/EDF/WAO guideline for the definition, classification, diagnosis and management of urticaria. Allergy. 2018;73(7):1393-1414.[PubMed 29336054]

Brand Names: International

Aerotina (AR); Agistam (UA); Alaron (BD); Albatrina (MX); Alerfast (PE); Alergit (EC); Alernitis (ID); Alert (BD); Alertin (VN); Alledine (AU); Allereze (AU); Allergiraz (EG); Allergyn (SG); Allergyx (IL); Allerta (PH); Allertyn (HK); Allohex (ID); Allor (HK); Alloris (SG); Ardin (SG); Avotyne (MY); Bonalerg (GT); Caradine (TH); Carin (MY); Carinose (TH); Civeran (ES); Cladin (BD); Clalodine (TH); Clara (QA, SA); Claratyne (AU, CY, NZ); Clarid (TH); Clarihist (PH); Clarin (AE, CY, IQ, IR, JO, KW, LY, OM, SA, SY, YE); Clarinese (ZA); Claritin (BB, BR, PH); Claritine (AE, BE, BF, BG, BH, BJ, BM, BS, BZ, CH, CI, CY, CZ, EE, EG, ET, GH, GM, GN, GY, HR, HU, IQ, IR, JM, JO, KE, KW, LB, LR, LT, LU, LV, LY, MA, ML, MR, MU, MW, NE, NG, NL, OM, PK, PL, PT, RO, RU, SA, SC, SD, SI, SK, SL, SN, SR, SY, TN, TR, TT, TZ, UG, YE, ZM); Clarityn (AT, DK, FI, GB, IE, IS, IT, NO, SE); Clarityne (AR, CL, CN, CO, CR, DO, ES, FR, GR, GT, HK, HN, KR, LK, MX, MY, NI, PA, PE, PY, SV, TH, TW, UY, VE, VN); CPLoradine (HK); Cronitin (ID); Curyken (MX); Dimegan (MX); Dymaten (MX); Efectine (MX); Emilora (LB); Erolin (BM, BS, BZ, GY, JM, SR, TT, VN); Ezede (SG); Finska (TW); Frenaler (CL); Fristamin (IT); Genadine (TW); Glora (QA); Halodin (TH); Histaclar (IE); Histafax (CR, DO, GT, HN, NI, PA, SV); Inigrin (MX); J-Tadine (KR); Klarihist (AE, CY, IQ, IR, JO, KW, LY, OM, SA, SY, YE); Klinset (ID); Laredine (AE, CY, IQ, IR, JO, KW, LY, OM, SA, SY, YE); Laritol (MX); Larotin (EC); Laura (ZA); Lertamine (MX); Lisino (DE); Lobeta (DE); Lodin (BD); Lohist (BH, JO, KW, QA, SA); Lora (TW); Lora-Lich (DE); Lora-Tabs (NZ); Lorabasics (DE); Loraclar (DE); Loraclear Hayfever Relief (NZ); Loradad (LB); Loraday (ET); Loraderm (DE); Loradin (HK); Loradine (ET); Lorahist (PH); Lorakine (QA); Loralerg (DE); Lorano (AU, DE, EG, PH, ZA, ZW); Lorastine (IL); Lorat (IE); Loratadura (DE); Loratan (AE, CY, IQ, IR, JO, KW, LY, OM, SA, SY, YE); Loratin (AE, QA, TZ, ZW); Loraton (HK); Loratrim (IL); Loratyne (PH); Lordamin (TH); Lorfast (BF, BJ, CI, ET, GH, GM, GN, IN, KE, LR, MA, ML, MR, MU, MW, NE, NG, SC, SD, SL, SN, TN, TZ, UG, ZM); Lorid (LK); Loridin (BF, BJ, CI, ET, GH, GM, GN, KE, LR, MA, ML, MR, MU, MW, NE, NG, SC, SD, SG, SL, SN, TN, TZ, UG, ZM); Lorihis (ID); Lorimox (MX); Lorin (IN); Lorine (BH, JO, KW); Lorita (HK, TH); Lorizan (UA); Lotan (MX); Lotarin (TW); Mosedin (AE, CY, IQ, IR, JO, KW, LY, OM, SA, SY, YE); Nasaler (PE); Neoalexil (MX); Neoday (BH, QA); Noseling (TW); NT-Alergi (HK); Nufalora (ID); Orin (LK); Pylor (ID); Rahistin (ID); Restamin (QA); Restamine (AE, CY, IQ, IR, JO, KW, LY, OM, SA, SY, YE); Ridamin (SG); Rinityn (PH, SG); Rityne (TH); Rotifar (MY); Roustadin (VN); Rupton (BE); Sanelor (LU); Sensibit (MX); Sensibit XP (CR, DO, GT, HN, NI, PA, SV); Sinaler (PY); Soneryl (ID); Sunadine (MY); Tidilor (AE, CY, ET, IQ, IR, JO, KW, LY, OM, SA, SY, YE); Tinnic (ID); Tricel (EC); Vincidal (MX); XSM (CN)

Loratadine (Patient Education – Adult Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(lor AT a deen)

Brand Names: US

Alavert [OTC]; Allergy Non-Drowsy [OTC]; Allergy Relief For Kids [OTC] [DSC]; Allergy Relief [OTC]; Allergy [OTC]; Childrens Loratadine [OTC]; Claritin Allergy Childrens [OTC]; Claritin Childrens [OTC]; Claritin Reditabs [OTC]; Claritin [OTC]; Loradamed [OTC]; Loratadine Childrens [OTC]; Loratadine Hives Relief [OTC] [DSC]; QlearQuil 24 Hour Relief [OTC] [DSC]; Triaminic Allerchews [OTC]

Brand Names: Canada

Apo-Loratadine; Claritin®; Claritin® Kids

What is this drug used for?
  • It is used to ease allergy signs.
  • It is used to treat hives.
What do I need to tell my doctor BEFORE I take this drug?
  • If you have an allergy to loratadine or any other part of this drug.
  • 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.
  • This drug 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 this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take this drug?
  • Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
  • This drug may affect certain lab tests. Tell all of your health care providers and lab workers that you take this drug.
  • Taking this drug in high doses may make you feel sleepy. Do not take more than your doctor or the package label tells you.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this drug while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
What are some side effects that I need to call my doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Feeling very tired or weak.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
  • Headache.
  • Feeling sleepy.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best taken?
  • Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.
  • All products:
  • Take with or without food. Take with food if it causes an upset stomach.
  • Chewable tablet:
  • If you have phenylketonuria (PKU), talk with your doctor. Some products have phenylalanine.
  • Chew well before swallowing.
  • Oral-disintegrating tablet:
  • If you have phenylketonuria (PKU), talk with your doctor. Some products have phenylalanine.
  • Do not take this drug out of the blister pack until you are ready to take it. Take this drug right away after opening the blister pack. Do not store the removed drug for future use.
  • Do not push the tablet out of the foil when opening. Use dry hands to take it from the foil. Place on your tongue and let it dissolve. Water is not needed. Do not swallow it whole. Do not chew, break, or crush it.
  • Liquid:
  • If you are on a low-salt diet (this drug has salt), talk with your doctor.
  • Measure liquid doses carefully. Use the measuring device that comes with this drug. If there is none, ask the pharmacist for a device to measure this drug.
What do I do if I miss a dose?
  • If you take this drug on a regular basis, take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.
  • Many times this drug is taken on an as needed basis. Do not take more often than told by the doctor.
How do I store and/or throw out this drug?
  • All products:
  • Store at room temperature. Do not freeze.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
  • Oral-disintegrating tablet:
  • Store in original container.
General drug facts
  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else’s drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
Loratadine (Patient Education – Pediatric Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(lor AT a deen)

Brand Names: US

Alavert [OTC]; Allergy Non-Drowsy [OTC]; Allergy Relief For Kids [OTC] [DSC]; Allergy Relief [OTC]; Allergy [OTC]; Childrens Loratadine [OTC]; Claritin Allergy Childrens [OTC]; Claritin Childrens [OTC]; Claritin Reditabs [OTC]; Claritin [OTC]; Loradamed [OTC]; Loratadine Childrens [OTC]; Loratadine Hives Relief [OTC] [DSC]; QlearQuil 24 Hour Relief [OTC] [DSC]; Triaminic Allerchews [OTC]

Brand Names: Canada

Apo-Loratadine; Claritin®; Claritin® Kids

What is this drug used for?
  • It is used to ease allergy signs.
  • It is used to treat hives.
What do I need to tell the doctor BEFORE my child takes this drug?
  • If your child has an allergy to this drug or any part of this drug.
  • If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • This drug may interact with other drugs or health problems.
  • Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take this drug with all of his/her drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.
What are some things I need to know or do while my child takes this drug?
  • Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
  • This drug may affect certain lab tests. Tell all of your child’s health care providers and lab workers that your child takes this drug.
  • Taking this drug in high doses may make your child feel sleepy. Do not give more than the doctor or the package label tells you.
  • If your child is pregnant or breast-feeding a baby:
  • Talk with the doctor if your child is pregnant, becomes pregnant, or is breast-feeding a baby. You will need to talk about the benefits and risks to your child and the baby.
What are some side effects that I need to call my child’s doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child’s doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Feeling very tired or weak.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:
  • Headache.
  • Feeling sleepy.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best given?
  • Give this drug as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.
  • All products:
  • Give this drug with or without food. Give with food if it causes an upset stomach.
  • Chewable tablet:
  • If your child has phenylketonuria (PKU), talk with your child’s doctor. Some products have phenylalanine.
  • Have your child chew all the way up before swallowing.
  • Oral-disintegrating tablet:
  • If your child has phenylketonuria (PKU), talk with your child’s doctor. Some products have phenylalanine.
  • Do not remove the tablet from the tablet pack until you are ready to put in this drug. Put in the tablet right away after opening the blister pack. Do not store the removed tablet for future use.
  • Do not push the tablet out of the foil when opening. Use dry hands to take it from the foil. Place on your child’s tongue and let it dissolve. Water is not needed. Do not let your child swallow it whole. Do not let your child chew, break, or crush it.
  • Liquid:
  • If your child is on a low-salt diet (this drug has salt), talk with your child’s doctor.
  • Measure liquid doses carefully. Use the measuring device that comes with this drug. If there is none, ask the pharmacist for a device to measure this drug.
What do I do if my child misses a dose?
  • If your child takes this drug on a regular basis, give a missed dose as soon as you think about it.
  • If it is close to the time for your child’s next dose, skip the missed dose and go back to your child’s normal time.
  • Do not give 2 doses at the same time or extra doses.
  • Many times this drug is given on an as needed basis. Do not give to your child more often than told by the doctor.
How do I store and/or throw out this drug?
  • All products:
  • Store at room temperature. Do not freeze.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
  • Oral-disintegrating tablet:
  • Store in original container.
General drug facts
  • If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
  • Do not share your child’s drug with others and do not give anyone else’s drug to your child.
  • Keep a list of all your child’s drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child’s doctor.
  • Talk with your child’s doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.