Metoclopramidemonohydrochloride may be available in the countries listed below.
Metoclopramide hydrochloride (a derivative of Metoclopramide) is reported as an ingredient of Metoclopramidemonohydrochloride in the following countries:
International Drug Name Search
Class: Second Generation Antihistamines
ATC Class: R06AX13
VA Class: AH109
Chemical Name: 4-(8-Chloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-b]pyr idin-11-ylidene)-1-piperidinecarboxylateethyl ester
Molecular Formula: C22H23ClN2O2
CAS Number: 79794-75-5
Brands: Alavert, Claritin, Claritin-D
Second generation antihistamine;1 2 3 4 5 6 7 8 9 10 36 37 45 46 derivative of azatadine.7 10 31 37 44
Self-medication for symptomatic relief (alone or in fixed combination with pseudoephedrine sulfate) of seasonal allergic rhinitis (e.g., hay fever);1 3 4 5 7 8 18 19 44 67 70 71 72 73 74 75 76 77 use fixed combination preparations only when both antihistamine and nasal decongestant activity are desired.18 19
As effective as astemizole (no longer commercially available in the US),4 7 39 azatadine,10 39 chlorpheniramine,7 39 clemastine,4 7 37 39 or terfenadine (no longer commercially available in the US).4 5 7 21 37 39
Has been used for the symptomatic treatment of perennial allergic rhinitis†.39
Self-medication for symptomatic relief of pruritus, erythema, and urticaria associated with chronic idiopathic urticaria (e.g., hives);1 15 16 17 21 78 not for prevention of chronic idiopathic urticaria or allergic skin reactions.78
Administer conventional tablets, orally disintegrating tablets, and fixed-combination tablets orally1 2 3 4 5 6 7 8 18 19 67 70 71 72 73 74 76 77 without regard to meals.1 18 20
Orally disintegrating tablets: Place tablet on the tongue, allow it to disintegrate (within a few seconds), then swallow with or without water.1 68 71
Fixed-combination loratadine/pseudoephedrine tablets: Swallow whole; do not break, crush, chew, or dissolve.18 19 70 73 75 76 Administer Claritin-D 24 Hour tablets with a full glass of water.19 70
Fixed-combination tablets formulated for 12-hour dosing contain 5 mg of loratadine and 60 mg of pseudoephedrine sulfate in an immediate-release outer shell and 60 mg of pseudoephedrine sulfate in an extended-release matrix core that slowly releases the drug.18
Fixed-combination tablets formulated for 24-hour dosing contain 10 mg of loratadine in an immediate-release outer shell and 240 mg of pseudoephedrine sulfate in an extended-release matrix core that slowly releases the drug.19 20
Self-medication in children 2 to <6 years of age:65 66 5 mg once daily (as oral solution).1 72
Self-medication in children ≥6 years of age:65 66 10 mg once daily (as conventional or orally disintegrating tablets or oral solution).1 5 7 10 67 68 69 74 77
Self-medication in children ≥12 years of age:65 66 5 mg every 12 hours (in fixed combination with 120 mg pseudoephedrine sulfate as the 12-hour formulation [e.g., Alavert Allergy & Sinus, Claritin-D 12 Hour])18 73 75 76 or 10 mg once daily (in fixed combination with 240 mg pseudoephedrine sulfate as the 24-hour formulation [Claritin-D 24 Hour]).19 70
Children 2–5 years of age: Not recommended for self-medication;78 a dosage of 5 mg once daily (as oral solution) has been recommended when clinicians prescribe the drug in children 2–5 years of age.1
Self-medication in children ≥6 years of age: 10 mg once daily.1 78
Self-medication:65 66 10 mg once daily (as conventional or orally disintegrating tablets or oral solution).1 5 7 10 67 68 69 74 77
Self-medication: 5 mg every 12 hours (in fixed combination with 120 mg pseudoephedrine sulfate as the 12-hour formulation)18 73 75 76 or 10 mg once daily (in fixed combination with 240 mg pseudoephedrine sulfate as the 24-hour formulation).19 70
Self-medication: 10 mg once daily.1 78
Self-medication65 66 in children 2 to <6 years of age: Maximum 5 mg once daily (as oral solution).72
Self-medication65 66 in children ≥6 years of age: Maximum 10 mg once daily (as conventional or orally disintegrating tablets or oral solution).67 68 71 77
Self-medication in children ≥12 years of age: Maximum 10 mg daily (in fixed combination with pseudoephedrine sulfate as the 12-hour or 24-hour formulations).70 73 76
Self-medication65 66 : Maximum 10 mg once daily (as conventional or orally disintegrating tablets or oral solution).67 68 71 77
Self-medication: Maximum 10 mg daily (in fixed combination with pseudoephedrine sulfate as the 12-hour or 24-hour formulations).70 73 76
Self-medication: Consult a clinician.67 70 71 72 78
Children 2–5 years of age with hepatic failure: 5 mg every other day (as oral solution).1
Adults and children ≥6 years of age with hepatic failure: 10 mg every other day (as conventional or orally disintegrating tablets or oral solution).1 18
Fixed-combination loratadine/pseudoephedrine sulfate preparations generally should not be used in patients with hepatic impairment.18 19
Self-medication: Consult a clinician.67 70 71 72 78
Children 2–5 years of age with renal insufficiency (glomerular filtration rate <30 mL/minute): 5 mg every other day (as oral solution).1
Adults and children ≥6 years of age with renal insufficiency (glomerular filtration rate <30 mL/minute): 10 mg every other day (as conventional or orally disintegrating tablets or oral solution).1 18
Fixed-combination loratadine/pseudoephedrine sulfate preparations in adults and children ≥12 years of age with renal insufficiency (glomerular filtration rate <30 mL/minute): 5 mg of loratadine once daily (when the 12-hour formulation is used) or 10 mg of loratadine every other day (when the 24-hour formulation is used).18 19
Known hypersensitivity to loratadine or any ingredient in the formulation.1 18 19
Alavert orally disintegrating tablets contain aspartame (NutraSweet), which is metabolized in the GI tract to provide 8.4 mg of phenylalanine per tablet.68
Possible rash.1 Urticaria, pruritus, purpura, photosensitivity reaction, erythema multiforme, and anaphylaxis reported rarely.1 18 19
When using fixed-combination preparation containing pseudoephedrine sulfate, consider the cautions, precautions, and contraindications associated with pseudoephedrine.18 19
Mechanical upper GI obstruction and esophageal perforation reported rarely with a previously marketed formulation of Claritin-D 24 Hour tablets;19 30 individuals with a history of difficulty in swallowing tablets, a known upper GI narrowing, or abnormal esophageal peristalsis should not use the Claritin-D 24 Hour preparation since it is not known whether the currently commercially available formulation has potential for this effect.19 30
Category B.1 18 19
Loratadine and its active metabolite desloratadine distribute readily into milk; pseudoephedrine (a component of fixed combination preparations) also distributes into milk.1 18 19 Caution advised; discontinue nursing or the drug.1 18 19
Safety and efficacy of loratadine alone or in fixed combination with pseudoephedrine sulfate not established in children <2 or <12 years of age, respectively.1 18 19
Risk of overdosage and toxicity (including death) in children <2 years of age receiving OTC preparations containing antihistamines, cough suppressants, expectorants, and nasal decongestants alone or in combination for relief of symptoms of upper respiratory tract infection.83 84 Limited evidence of efficacy for these preparations in this age group; appropriate dosages not established.83 Therefore, FDA recommended not to use such preparations in children <2 years of age; safety and efficacy in older children currently under evaluation. Because children 2–3 years of age also are at increased risk of overdosage and toxicity, some manufacturers of oral nonprescription cough and cold preparations recently agreed to voluntarily revise the product labeling to state that such preparations should not be used in children <4 years of age. During the transition period, some preparations on pharmacy shelves will have the new recommendation (“do not use in children <4 years of age”), while others will have the previous recommendation (“do not use in children <2 years of age”). FDA recommends that parents and caregivers adhere to dosage instructions and warnings on the product labeling that accompanies the preparation and consult a clinician about any concerns. Clinicians should ask caregivers about use of OTC cough/cold preparations to avoid overdosage.
Conventional or orally disintegrating tablets or oral solution: Risk of somnolence.1 Because geriatric patients frequently have decreased renal function, evaluate renal function prior to initiation and subsequently thereafter in this age group; adjust dosage if renal impairment exists or develops.1
Fixed-combination loratadine/pseudoephedrine sulfate preparations: Safety and efficacy not studied in patients ≥60 years of age.18 19 Geriatric patients are more likely to have adverse effects from sympathomimetic amines than younger patients.18 19
Conventional or orally disintegrating tablets or oral solution: Dosage adjustment recommended.1 (See Hepatic Impairment under Dosage and Administration.)
Fixed-combination loratadine/pseudoephedrine sulfate preparations: Use not recommended.18 19
Conventional or orally disintegrating tablets or oral solution: Dosage adjustment recommended.1 (See Renal Impairment under Dosage and Administration.)
Fixed-combination loratadine/pseudoephedrine preparations: Dosage adjustment recommended.18 19 (See Renal Impairment under Dosage and Administration.)
Children 2–5 years of age receiving oral solution: Diarrhea, epistaxis, pharyngitis, flu-like symptoms, fatigue, stomatitis, tooth disorder, earache, viral infection, rash.1
Children 6–12 years of age receiving oral solution: Nervousness, wheezing, fatigue, hyperkinesia, abdominal pain, conjunctivitis, dysphonia, upper respiratory tract infection.1
Adults and children ≥12 years of age receiving conventional or orally disintegrating tablets: Headache, somnolence, fatigue, dry mouth.1
Fixed combination loratadine/pseudoephedrine sulfate preparations: Insomnia, dry mouth, headache, somnolence, nervousness, dizziness, fatigue.18 19
Metabolized principally by CYP3A4 and to lesser extent by CYP2D6.1 39
No formal drug interaction studies conducted with fixed combination loratadine/pseudoephedrine preparations.18 19 When using these preparations, consider drug interactions associated with pseudoephedrine.18 19
Inhibitors of CYP3A4 or CYP2D6: Potential pharmacokinetic interaction (increased plasma concentrations of loratadine and desloratadine).1 18 19 39 64 (See Specific Drugs under Interactions.)
Drug | Interaction | Comments |
|---|---|---|
Cimetidine | Increased loratadine and desloratadine concentrations; no clinically important changes in ECG or laboratory evaluations, vital signs, or adverse effects reported1 18 19 39 64 | |
Ketoconazole | Increased loratadine and desloratadine concentrations; no clinically important changes in ECG or laboratory evaluations, vital signs, or adverse effects reported1 18 19 39 64 | |
Macrolide antibiotics (e.g., clarithromycin, erythromycin) | Increased loratadine and desloratadine concentrations; no clinically important changes in ECG or laboratory evaluations, vital signs, or adverse effects reported1 18 19 39 64 |
Rapidly absorbed from the GI tract following oral administration;1 10 18 19 37 38 39 42 49 in animal studies, 85% of an oral dose was absorbed.7 41 43 Peak plasma concentrations are attained in about 1.5–3.7 hours.10
Antihistaminic effect is apparent within 1–4 hours.1 10 18 19 36 39
Antihistaminic effect persists for 12–24 hours.1 2 10 18 19 38 46 61
Food increases the extent of loratadine absorption and delays time to peak plasma concentration by about 1 hour.1 18 19
In patients with hepatic impairment, increased peak plasma loratadine concentrations and AUC secondary to impaired drug metabolism can occur.1 7 10 18 19 39
In patients with chronic renal impairment (Clcr ≤30 mL/minute), peak plasma concentrations and AUC of loratadine and desloratadine are increased compared with those in adults with normal renal function.1 4 18 19 38
In geriatric patients, peak plasma concentrations and AUC of loratadine and desloratadine are increased compared to those in younger adults.1 18 19
Distribution has not been determined.10 Neither the drug nor its metabolites appear to cross the blood-brain barrier.1 18 19 Loratadine and its metabolites are distributed into breast milk in concentrations that are equivalent to plasma concentrations.1 7 10 18 19 40
97–99% (loratadine); 73–77% (desloratadine).7 10 18 19 39 40
Extensive first-pass metabolism by CYP enzymes in the liver to the active desloratadine metabolite.1 18 19 39 41 44 49 50 Metabolized principally by CYP3A4 and to lesser extent by CYP2D6.1 39
Excreted equally in urine and feces as metabolic products.1 18 19
The mean distribution half-life of loratadine is about 1–2 hours;7 10 37 41 42 the mean elimination half-life is 8–15 hours.1 7 10 18 19 37 41 42 44 49 The mean distribution half-life of desloratadine is about 2–4 hours;7 10 41 42 the mean elimination half-life is 17–28 hours.1 7 10 18 19 41 42 44 49
In patients with hepatic impairment, elimination half-life of loratadine and desloratadine is increased with increasing severity of hepatic disease.1 7 10 18 19 39
In patients with renal impairment (Clcr ≤30 mL/minute), mean elimination half-lives of loratadine and desloratadine appear to be similar to those in patients with normal renal function.1 4 10 18 19 39 43
In a limited number of geriatric patients (66–78 years of age), half-lives of loratadine and desloratadine were increased compared to those in younger adults.1 18 19
2–30°C.1 Protect from excessive moisture.67 77 78
2–25°C.68 71 Use tablet immediately after opening individual blister; use within 6 months of opening foil pouch.71
2–25°C.72
15–25°C.70 73 76
Exhibits specific, selective peripheral H1-receptor antagonistic activity.1 2 3 4 5 6 7 8 9 10 36 37 45 46
No appreciable anticholinergic7 10 49 or α-adrenergic blocking7 10 37 51 activity in vitro.
In clinical studies, incidence of CNS effects (e.g., sedation, impaired psychomotor performance) associated with loratadine is similar to that with placebo or terfenadine (no longer commercially in the US) and less than that with first generation antihistamines (e.g., azatadine, chlorpheniramine, clemastine).1 7 10 18 19 37
For self-medication, importance of taking only as needed and not exceeding recommended dosage; taking more than recommended dosage may cause drowsiness.67 68 70 71 72 73 76 77
For self-medication with loratadine in fixed combination with pseudoephedrine, importance of discontinuing therapy and contacting a clinician if symptoms do not improve within 7 days or are accompanied by fever, or if nervousness, dizziness, or sleeplessness occurs.70 73 76
For self-medication for management of chronic idiopathic urticaria (e.g., hives), importance of understanding that loratadine does not prevent hives.78 Importance of consulting a clinician before initiating therapy if hives are unusual in color, look bruised or blistered, or do not itch.78 Importance of discontinuing therapy and contacting a clinician if symptoms do not improve within 3 days or if hives have persisted for >6 weeks.78
Importance of understanding that chronic idiopathic urticaria may present with other severe allergic reactions, including anaphylactic shock (e.g., trouble swallowing, swelling of the tongue, trouble speaking, wheezing or trouble breathing, dizziness or loss of consciousness, swelling in or around the mouth, drooling).78 These manifestations may occur when hives first appear or up to several hours later and can be life-threatening if not treated immediately.78 Importance of immediately seeking emergency help if anaphylactic shock occurs.78 If an epinephrine auto-injector has been prescribed, importance of carrying this device at all times; never use loratadine as a substitute for the epinephrine auto-injector.78
Importance of discontinuing the drug immediately and informing a clinician if an allergic or hypersensitivity reaction occurs.67 68 69 70 71 72 73 77
Importance of informing patients with phenylketonuria that some orally disintegrating tablet preparations (e.g. Alavert) contain aspartame.68
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses.1
Importance of patients with renal or hepatic impairment, heart disease, hypertension, thyroid disease, diabetes mellitus, or difficulty in urination resulting from prostate enlargement not undertaking self-medication without first consulting a clinician.1 70 73 75 (See Cautions.)
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1
Importance of informing patients of other important precautionary information.1 (See Cautions.)
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Solution | 5 mg/5 mL | Children's Claritin Fruit Flavored Syrup 24 Hour | Schering-Plough |
Children’s Claritin Allergy, Grape Flavor | Schering-Plough | |||
Tablets | 10 mg* | Alavert Non-Drowsy Allergy Relief 24 Hour | Wyeth | |
Claritin Hives Relief | Schering-Plough | |||
Claritin 24 Hour | Schering-Plough | |||
Tablets, orally disintegrating | 10 mg | Alavert Non-Drowsy Allergy Relief 24 Hour | Wyeth | |
Claritin Reditabs 24 Hour | Schering-Plough |
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Tablets, extended-release core (containing pseudoephedrine 60 mg) | 5 mg with Pseudoephedrine Sulfate 120 mg | Alavert Allergy & Sinus D-12 Hour | Wyeth |
Claritin-D 12 Hour | Schering-Plough | |||
Tablets, extended-release core (pseudoephedrine sulfate only), film-coated | 10 mg with Pseudoephedrine Sulfate 240 mg | Claritin-D 24 Hour | Schering-Plough |
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Claritin 10MG Tablets (SCHERING-PLOUGH HEALTHCARE): 30/$30.99 or 90/$70.97
Claritin 10MG Tablets (SCHERING-PLOUGH HEALTHCARE): 30/$35.99 or 90/$89.97
Claritin Reditabs 10MG Dispersible Tablets (SCHERING-PLOUGH HEALTHCARE): 10/$20.99 or 30/$41.97
Loratadine 10MG Tablets (SANDOZ): 30/$21.99 or 90/$60.97
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions November 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
† Use is not currently included in the labeling approved by the US Food and Drug Administration.
1. Schering Corp. Claritin tablets, syrup and rapidly disintegrating tablets prescribing information. Kenilworth, NJ; 2000 Sep.
2. Kassem N, Roman I, Gural R et al. Effects of loratadine (SCH 29851) in suppression of histamine-induced skin wheals. Ann Allergy. 1988; 60:505-7. [IDIS 223616] [PubMed 2968060]
3. Oei HD. Double-blind comparison of loratadine (SCH 29851), astemizole, and placebo in hay fever with special regard to onset of action. Ann Allergy. 1988; 61:436-9. [IDIS 310134] [PubMed 2904776]
4. Quercia RA, Broisman L. Focus on loratadine: a new second-generation nonsedating H1-receptor antagonist. Hosp Formul. 1993; 28:137-53.
5. Del Carpio JD, Kabbash L, Turenne Y et al. Efficacy and safety of loratadine (10 mg once daily), terfenadine (60 mg twice daily), and placebo in the treatment of seasonal allergic rhinitis. J Allergy Clin Immunol. 1989; 84:741-6. [IDIS 309183] [PubMed 2572617]
6. Simons FER. The antiallergic effects of antihistamines (H1-receptor antagonists). J Allergy Clin Immunol. 1992; 90:705-15. [IDIS 303368] [PubMed 1383310]
7. Barenholtz AH, McLeod DC. Loratadine: a nonsedating antihistamine with once-daily dosing. DICP. 1989; 23:445-50. [IDIS 254798] [PubMed 2525847]
8. Simons FE. Loratadine, a non-sedating H1-receptor antagonist (antihistamine). Ann Allergy. 1989; 63:266-8. [IDIS 300837] [PubMed 2572187]
9. Barnett A, Iorio LC, Kreutner W et al. Evaluation of the CNS properties of SCH 29851, a potential non-sedating antihistamine. Agents Actions. 1984; 14:590-7. [PubMed 6236679]
10. Clissold SP, Sorkin EM, Goa KL. Loratadine: a preliminary review of its pharmacodynamic properties and therapeutic efficacy. Drugs. 1989; 37:42-57. [IDIS 253577] [PubMed 2523301]
11. Borge PA. Problems in allergic rhinitis. Arzneimittelforschung. 1982; 32:1199-201. [PubMed 6891258]
12. Anon. Treatment of seasonal and perennial rhinitis. BMJ. 1981; 283:808-10. [PubMed 6117350]
13. Food and Drug Administration. Over-the-counter drugs: establishment of a monograph for OTC cold, cough, allergy, bronchodilator and antiasthmatic products. [21 CFR 341] Fed Regist. 1976; 41:38312-424. (IDIS 66640)
14. Douglas WW. Histamine and 5-hydroxytryptamine (serotonin) and their antagonists. In: Gilman AG, Goodman LS, Rall TW et al, eds. Goodman and Gilman’s the pharmacologic basis of therapeutics. 7th ed. New York: Macmillan Publishing Company; 1985:605-38.
15. Ormerod AD. Urticaria: recognition, causes and treatment. Drugs. 1994; 48:717-30. [IDIS 359176] [PubMed 7530629]
16. Monroe EW. Relative efficacy and safety of loratadine, hydroxyzine, and placebo in chronic idiopathic urticaria and atopic dermatitis. Clin Ther. 1992; 14:17-21. [PubMed 1349509]
17. Belaich B, Bruttmann D, DeGreef H et al. Comparative effects of loratadine and terfenadine in the treatment of chronic idiopathic urticaria. Ann Allergy. 1990; 64:191-4. [IDIS 297021] [PubMed 1967919]
18. Schering Corp. Claritin-D 12 Hour (loratadine and pseudoephedrine sulfate) extended-release tablets prescribing information. Kenilworth, NJ; 1998 May.
19. Schering Corp. Claritin-D 24 Hour (loratadine and pseudoephedrine sulfate) extended-release tablets prescribing information. Kenilworth, NJ; 1998 Apr.
20. Schering Corp, Kenilworth, NJ: Personal communication.
21. 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; 15:855-65. [PubMed 8269452]
22. Meltzer EO, Weiler JM, Widlitz MD. Comparative outdoor study of the efficacy, onset and duration of action, and safety of cetirizine, loratadine, and placebo for seasonal allergic rhinitis. J Allergy Clin Immunol. 1996; 97:617-26. [IDIS 360732] [PubMed 8621847]
23. Simons FER. Hl-Receptor antagonists: comparative tolerability and safety. Drug Saf. 1994; 10:350-80. [IDIS 359177] [PubMed 7913608]
24. Gosselin RE, Smith RP, Hodge HC. Clinical toxicology of commercial products. 5th ed. Baltimore: Williams & Wilkins; 1984:I10,III-36-40.
25. Cirillo VJ, Tempero KF. The pharmacology and therapeutic use of H1 and H2 antihistamines. In: Miller RR, Greenblatt DJ, eds. Drug therapy reviews. Vol 2. New York: Elsevier/North Holland Inc; 1979:24-47.
26. AMA Division of Drugs. AMA drug evaluations. 5th ed. Chicago: American Medical Association; 1983:1465-79.
27. Church JA. Allergic rhinitis: diagnosis and management. Clin Pediatr. (Philadelphia). 1980; 19:655-9.
28. Food and Drug Administration. Cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use; tentative final monograph for OTC antihistamine drug products. [21 FR Part 341] Fed Regist. 1985; 50:2200-18. (IDIS 195256)
29. Holgate S. Comparative trial of two non-sedative H1 antihistamines, terfenadine and astemizole, for hay fever. Thorax. 1985; 40:399.
30. Harris AG. Dear doctor letter regarding mechanical upper GI obstruction with Claritin-D 24 Hour tablets. Kenilworth, NJ: Schering Corporation; 1997 Jul.
31. Villani FJ, Magatti CV, Vashi DB et al. N-substituted 11-(4-piperidylene)-5,6-dihydro-11H-benzo-[5,6]cyclohepta[1,2b]pyrid ines. Antihistamines with no sedating liability. Arzneimittelforschung. 1986; 36:1311-4. [PubMed 2947582]
32. IorioLC, Cohen-Winston M, Barnett A. Interaction studies in mice of SCH 29851, a potential non-sedating antihistamine, with commonly used therapeutic agents. Agents Actions. 1986; 18:485-93. [PubMed 2945410]
33. Sorkin EM, Heel RC. Terfenadine: a review of its pharmacodynamic properties and therapeutic efficacy. Drugs. 1985; 29:34-56. [IDIS 197286] [PubMed 2857636]
34. Moser L, Huther KJ, Koch-Weser J et al. Effects of terfenadine and diphenhydramine alone or in combination with diazepam or alcohol on psychomotor performance and subjective feelings. Eur J Clin Pharmacol. 1978; 14:417-23. (IDIS 110254)
35. Bousquet J, Chanal I, Skassa-Brociek W et al. Lack of subsensitivity to loratadine during long-term dosing during 12 weeks. J Allergy Clin Immunol. 1990; 86:248-53. [IDIS 287716] [PubMed 1974561]
36. Roman IJ, Kassem N, Gural RP et al. Suppression of histamine-induced wheal response by loratadine (SCH 29851) over 28 days in man. Ann Allergy. 1986; 57:253-6. [IDIS 223656] [PubMed 2945499]
37. Dockhorn RJ, Bergner A, Connell JT et al. Safety and efficacy of loratadine (Sch- 29851): a new non-sedating antihistamine in seasonal allergic rhinitis. Ann Allergy. 1987; 58:407-11. [IDIS 316934] [PubMed 2954497]
38. Desager J, Horsmans Y. Pharmacokinetic-pharmacodynamic relationships of H1- antihistamines. Clin Pharmacokinet. 1995; 28:419-32. [IDIS 360835] [PubMed 7614779]
39. Haria M, Fitton A, Peters DH. Loratadine. A reappraisal of its pharmacological properties and therapeutic use in allergic disorders. Drugs. 1994; 48:617-37. [IDIS 359175] [PubMed 7528133]
40. Hilbert J, Radwanski E, Affrime MB et al. Excretion of loratadine in breast milk. J Clin Pharmacol. 1988; 28:234-9. [IDIS 239877] [PubMed 2966185]
Betadine Alcoholic Solution.
Povidone iodine 10.0% w/v.
Alcoholic solution.
For use as an antiseptic skin cleanser for major and minor surgical procedures where a quick drying effect is desired.
For topical administration.
Known or suspected iodine hypersensitivity. Regular use is contraindicated in patients and users with thyroid disorders (in particular nodular colloid goitre, endemic goitre and Hashimoto's thyroiditis).
Special caution is needed when regular applications to broken skin are made to patients with pre-existing renal insufficiency.
Absorption of iodine from povidone iodine through either intact or damaged skin may interfere with thyroid function tests. Contamination with povidone iodine of several types of tests for the detection of occult blood in faeces or blood in urine may produce false-positive results.
Regular use of povidone iodine should be avoided in pregnant or lactating women as absorbed iodine can cross the placental barrier and can be secreted into breast milk. Although no adverse effects have been reported from limited use, caution should be recommended and therapeutic benefit must be balanced against possible effects of the absorption of iodine on foetal thyroid function and development.
None known.
Povidone iodine may produce local skin reactions, although it is considered to be less irritant than iodine. The application of povidone iodine to large wounds or severe burns may produce systemic adverse effects such as metabolic acidosis, hypernatraemia and impairment of renal function.
Excess iodine can produce goitre and hypothyroidism or hyperthyroidism. Systemic absorption of iodine after repeated application of povidone iodine to large areas of wounds or burns may lead to a number of adverse effects: metallic taste in mouth, increased salivation, burning or pain in the throat or mouth, irritation and swelling of the eyes, pulmonary oedema, skin reactions, gastrointestinal upset and diarrhoea, metabolic acidosis, hypernatraemia and renal impairment. Treatment: In the case of accidental ingestion of large quantities of Betadine symptomatic and supportive treatment should be provided, with special attention to electrolyte balance and renal and thyroid function.
The active ingredient, povidone iodine, slowly liberates iodine when in contact with skin and mucous membranes. The activity of 'iodine' as a microbicide is then governed by a series of dissociations: I2↔ I+ + I- ; I2 + H2O ↔ H2O I+ + I- ; I2 + I- ↔ I3-. The microbicidal species H2O I+ preferentially displaces oxygen as the end electron acceptor in the microorganism's respiratory cycle. H2O I+ similarly interacts within the electron transport chain and reacts with the amino acids of the microbial cell membrane.
Betadine Alcoholic Solution is for topical application and therefore a consideration of the absorption, distribution, metabolism and excretion of povidone iodine is largely without relevance.
Not applicable.
Nonoxynol 9; dibasic sodium phosphate (anhydrous); citric acid monohydrate; glycerol; industrial methylated spirit; sodium hydroxide; purified water.
None.
36 months.
To be stored at or below 25 degrees Celsius and protected from light.
High-density polyethylene containers fitted with steran lined white polypropylene caps. Pack size: 500ml
None stated.
Medlock Medical Limited, Tubiton House, Medlock Street, Oldham, OL1 3HS.
PL 21248/0002.
14th March 2005.
March 2005.
*Lac-Hydrin is a formulation of 12% lactic acid neutralized with ammonium hydroxide, as ammonium lactate with a pH of 4.4-5.4. Lac-Hydrin® 12% (ammonium lactate) Cream also contains cetyl alcohol, glycerin, glyceryl stearate, laureth-4, light mineral oil, magnesium aluminum silicate, methylcellulose, methyl and propyl parabens, PEG-100 stearate, polyoxyl 40 stearate, propylene glycol and water. Lactic acid is a racemic mixture of 2-hydroxypropanoic acid and has the following structural formula:
Lactic acid is an alpha-hydroxy acid. It is a normal constituent of tissues and blood. The alpha-hydroxy acids (and their salts) are felt to act as humectants when applied to the skin. This property may influence hydration of the stratum corneum. In addition, lactic acid, when applied to the skin, may act to decrease corneocyte cohesion. The mechanism(s) by which this is accomplished is not yet known.
An in vitro study of percutaneous absorption of Lac-Hydrin Cream using human cadaver skin indicates that approximately 6.1% of the material was absorbed after 68 hours.
Lac-Hydrin Cream is indicated for the treatment of ichthyosis vulgaris and xerosis.
Lac-Hydrin Cream is contraindicated in those patients with a history of hypersensitivity to any of the label ingredients.
Sun exposure to areas of the skin treated with Lac-Hydrin Cream should be minimized or avoided (see PRECAUTIONS section).The use of Lac-Hydrin Cream should be discontinued if any hypersensitivity is observed.
For external use only. Stinging or burning may occur when applied to skin with fissures, erosions, or that is otherwise abraded (for example, after shaving the legs).Caution is advised when used on the face because of the potential for irritation. The potential for post-inflammatory hypo- or hyperpigmentation has not been studied.
Patients using Lac-Hydrin Cream should receive the following information and instructions:
The topical treatment of CD-1 mice with 12%, 21% or 30% ammonium lactate formulations for two years did not produce a significant increase in dermal or systemic tumors in the absence of increased exposure to ultraviolet radiation. The maximum systemic exposure of the mice in this study was 0.7 times the maximum possible systemic exposure in humans. However, a long-term photocarcinogenicity study in hairless albino mice suggested that topically applied 12% ammonium lactate cream enhanced the rate of ultraviolet light-induced skin tumor formation.
The mutagenic potential of ammonium lactate cream was evaluated in the Ames assay and in the mouse in vivo micronucleus assay, both of which were negative.
In dermal Segment I and III studies with ammonium lactate cream there were no effects observed in fertility or pre- or post-natal development parameters in rats at dose levels of 300 mg/kg/day (1800 mg/m2/day), approximately 0.4 times the human topical dose.
Teratogenic effects: Pregnancy Category B.
Animal reproduction studies have been performed in rats and rabbits at doses up to 0.7 and 1.5 times the human dose, respectively (600 mg/kg/day, corresponding to 3600 mg/m2/day in the rat and 7200 mg/m2/day in the rabbit) and have revealed no evidence of impaired fertility or harm to the fetus due to ammonium lactate cream. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Lac-Hydrin Cream should be used during pregnancy only if clearly needed.
Although lactic acid is a normal constituent of blood and tissues, it is not known to what extent this drug affects normal lactic acid levels in human milk. Because many drugs are excreted in human milk, caution should be exercised when Lac-Hydrin is administered to a nursing woman.
The safety and effectiveness of Lac-Hydrin Cream have been established in pediatric patients as young as 2 years old.
Clinical studies of Lac-Hydrin® (ammonium lactate) Cream, 12% did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients. In general, dose selection for an elderly patient should be cautious.
In controlled clinical trials of patients with ichthyosis vulgaris, the most frequent adverse reactions in patients treated with Lac-Hydrin Cream were rash (including erythema and irritation) and burning/stinging. Each was reported in approximately 10-15% of patients. In addition, itching was reported in approximately 5% of patients.
In controlled clinical trials of patients with xerosis, the most frequent adverse reactions in patients treated with Lac-Hydrin Cream were transient burning, in about 3% of patients, stinging, dry skin and rash, each reported in approximately 2% of patients.
Apply to the affected areas and rub in thoroughly. Use twice daily or as directed by a physician.
Lac-Hydrin® 12%* (ammonium lactate) Cream is available in cartons of 280 g (two 140 g plastic tubes) (NDC # 10631-099-28) and 385 g plastic bottle (NDC # 10631-099-38). Store at controlled room temperature, 15° C-30° C (59° F-86° F).
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| NDA | NDA020508 | 03/16/2009 | |
| Labeler - Ranbaxy Laboratories Inc. (169932519) |
| Registrant - Ranbaxy Laboratories Inc. (169932519) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Contract Pharmaceuticals Limited | 248761249 | manufacture | |
Generic Name: hydrocortisone butyrate (Topical application route)
hye-droe-KOR-ti-sone BUE-ti-rate
In the U.S.
In Canada
Available Dosage Forms:
Therapeutic Class: Corticosteroid, Intermediate
Pharmacologic Class: Hydrocortisone
Hydrocortisone butyrate topical is used to help relieve redness, itching, swelling, or other discomfort caused by skin conditions (e.g., atopic dermatitis, seborrheic dermatitis). This medicine is a corticosteroid (cortisone-like medicine or steroid).
This medicine is available only with your doctor's prescription.
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of hydrocortisone butyrate topical in children 3 months of age or older. However, because of this medicine's toxicity, it should be used with caution. Children may absorb large amounts through the skin, which can cause serious side effects. If your child is using this medicine, follow your doctor's instructions very carefully.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of hydrocortisone butyrate topical in the elderly.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
This section provides information on the proper use of a number of products that contain hydrocortisone butyrate. It may not be specific to Locoid Lipocream. Please read with care.
It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects or skin irritation.
This medicine is for use on the skin only. Do not get it in your eyes, nose, mouth, or vagina. Do not use it on skin areas that have cuts, scrapes, or burns. If it does get on these areas, rinse it off right away with water.
This medicine should only be used for skin conditions that your doctor is treating. Check with your doctor before using it for other conditions, especially if you think that a skin infection may be present. This medicine should not be used to treat certain kinds of skin infections or conditions, such as severe burns.
Do not use the topical cream or lotion on the face, groin, or underarms unless directed to do so by your doctor, and do not use these forms for more than 4 weeks.
To use:
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
It is very important that your doctor check the progress of you or your child at regular visits for any unwanted effects that may be caused by this medicine.
If your or your child's symptoms do not improve within a few days, or if they become worse, check with your doctor.
Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. The risk is greater for children and patients who use large amounts for a long time. Talk to your doctor right away if you or your child have more than one of these symptoms while you are using this medicine: blurred vision; dizziness or fainting; a fast, irregular, or pounding heartbeat; increased thirst or urination; irritability; or unusual tiredness or weakness.
Stop using this medicine and check with your doctor right away if you or your child have a skin rash, burning, stinging, swelling, or irritation on the skin.
Do not use cosmetics or other skin care products on the treated areas.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
See also: Locoid Lipocream Topical application side effects (in more detail)
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