Theralene Pectoral Nourrisson

Ammonium Acetate:

• Indications and usage
• Contraindications
• Warning
• Precautions
• Adverse reactions
• Overdosage
• Dosage and administration
• How supplied
• Theralene Pectoral Nourrisson (Ammonium Acetate) reviews

INDICATIONS AND USAGE

Theralene Pectoral Nourrisson (Ammonium Acetate) Lactate Lotion, 12% is indicated for the treatment of dry, scaly skin (xerosis) and ichthyosis vulgaris, and for the temporary relief of itching associated with these conditions.

CONTRAINDICATIONS

Theralene Pectoral Nourrisson (Ammonium Acetate) Lactate Lotion, 12% is contraindicated in those patients with a history of hypersensitivity to any of the label ingredients.

WARNING

Sun exposure (natural or artificial sunlight) to areas of the skin treated with Theralene Pectoral Nourrisson (Ammonium Acetate) Lactate Lotion, 12% should be minimized or avoided (see PRECAUTIONS). The use of Theralene Pectoral Nourrisson (Ammonium Acetate) Lactate Lotion, 12% should be discontinued if any hypersensitivity is observed.

PRECAUTIONS

General -

For external use only. Stinging or burning may occur when applied to skin with fissures, erosions, or that is otherwise abraded. 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.

Information for Patients

Patients using Theralene Pectoral Nourrisson (Ammonium Acetate) Lactate Lotion, 12% should receive the following information and instructions:

• This medication is to be used as directed by the physician, and should not be used for any disorder other than for which it was prescribed. It is for external use only. Avoid contact with eyes, lips, or mucous membranes.
• Patients should minimize or avoid use of this product on areas of the skin that may be exposed to natural or artificial sunlight, including the face. If sun exposure is unavoidable, clothing should be worn to protect the skin.
• This medication may cause transient stinging or burning when applied to skin with fissures, erosions, or abrasions (for example, after shaving the legs).
• If the skin condition worsens with treatment, the medication should be promptly discontinued.

Carcinogenesis, Mutagenesis, Impairment of Fertility -

The topical treatment of CD-1 mice with 12%, 21% or 30% Theralene Pectoral Nourrisson 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% Theralene Pectoral Nourrisson (Ammonium Acetate) lactate formulations enhanced the rate of ultraviolet light-induced skin tumor formation.

The mutagenic potential of Theralene Pectoral Nourrisson (Ammonium Acetate) lactate formulations 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 Theralene Pectoral Nourrisson (Ammonium Acetate) lactate formulations there were no effects observed in fertility or pre- or postnatal development parameters in rats at dose levels of 300 mg/kg/day (1800 mg/m²/day), approximately 0.4 times the human topical dose.

Pregnancy:

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 and have revealed no evidence of impaired fertility or harm to the fetus due to Theralene Pectoral Nourrisson (Ammonium Acetate) lactate formulations. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Theralene Pectoral Nourrisson (Ammonium Acetate) Lactate Lotion, 12% should be used during pregnancy only if clearly needed.

Nursing Mothers -

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 Theralene Pectoral Nourrisson (Ammonium Acetate) lactate is administered to a nursing woman.

Pediatric Use -

Safety and effectiveness of Theralene Pectoral Nourrisson lactate have been demonstrated in infants and children. No unusual toxic effects were reported.

Geriatric Use -

Clinical studies of Theralene Pectoral Nourrisson (Ammonium Acetate) lactate lotion, 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.

ADVERSE REACTIONS

The most frequent adverse experiences in patients with xerosis are transient stinging (1 in 30 patients), burning (1 in 30 patients), erythema (1 in 50 patients) and peeling (1 in 60 patients). Other adverse reactions which occur less frequently are irritation, eczema, petechiae, dryness, and hyperpigmentation. Due to the more severe initial skin conditions associated with ichthyosis, there was a higher incidence of transient stinging, burning and erythema (each occurring in 1 in 10 patients).

OVERDOSAGE

The oral administration of Theralene Pectoral Nourrisson (Ammonium Acetate) lactate to rats and mice showed this drug to be practically non-toxic (LD₅₀>15 mL/kg).

DOSAGE AND ADMINISTRATION

Shake well. Apply to the affected areas and rub in thoroughly. Use twice daily or as directed by a physician.

HOW SUPPLIED

Theralene Pectoral Nourrisson Lactate Lotion, 12% is available as follows:

225 g bottle (NDC 45802-419-54)

400 g bottle (NDC 45802-419-26)

STORAGE

Store at 20-25°C (68-77°F).

Manufactured By Perrigo, Bronx, NY 10457

Distributed By Perrigo, Allegan, MI 49010

0K5A7 RC F6

Rev 01-17

Trimeprazine Tartrate:

• Indications and usage
• Warning
• Precautions and side effects
• Dosage and administration
• How supplied
• References
• Theralene Pectoral Nourrisson (Trimeprazine Tartrate) reviews

INDICATIONS AND USAGE

1. Antipruritic

Theralene Pectoral Nourrisson is recommended for the relief of itching regardless of cause. Its usefulness has been demonstrated for the relief of itching and the reduction of inflammation commonly associated with most skin disorders of dogs such as the eczema caused by internal disorders, otitis, and dermatitis (allergic, parasitic, pustular, and nonspecific). It often relieves pruritus which does not respond to other therapy. With any pruritus treatment, the cause should be determined and corrected; otherwise, signs are likely to recur following discontinuance of therapy.

2. Antitussive

Theralene Pectoral Nourrisson (Trimeprazine Tartrate) has been found to be effective therapy and adjunctive therapy in various cough conditions of dogs. Therefore, in addition to its antipruritic action, Theralene Pectoral Nourrisson (Trimeprazine Tartrate) is recommended for the treatment of "kennel cough" or tracheobronchitis, bronchitis including all allergic bronchitis, and infections and coughs of nonspecific origin. (Coughs due to cardiac insufficiencies would not be expected to respond to Theralene Pectoral Nourrisson (Trimeprazine Tartrate) therapy.) As with any antitussive treatment, the etiology of the cough should be determined and eliminated if possible. Otherwise, symptoms are likely to recur following discontinuance of therapy.

Note: Theralene Pectoral Nourrisson (Trimeprazine Tartrate) may be administered to animals suffering from acute or chronic bacterial infections provided the infection is controlled by appropriate antibiotic or chemotherapeutic agents.

WARNING

Clinical and experimental data have demonstrated that corticosteroids administered orally or by injection to animals may induce the first stage of parturition if used during the last trimester of pregnancy and may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis. Additionally, corticosteroids administered to dogs, rabbits, and rodents during pregnancy have resulted in cleft palate in offspring. Corticosteroids administered to dogs during pregnancy have also resulted in other congenital anomalies, including deformed forelegs, phocomelia, and anasarca. If a vasoconstrictor is needed, norepinephrine should be used in lieu of epinephrine. Phenothiazine derivatives may reverse the usual elevating action of epinephrine causing a further lowering of blood pressure.

PRECAUTIONS AND SIDE EFFECTS

All the precautions applicable to cortisone and to phenothiazine derivatives apply also to Theralene Pectoral Nourrisson (Trimeprazine Tartrate). Possible side effects attributable to corticosteroids include sodium retention and potassium loss, negative nitrogen balance, suppressed adrenal cortical function, delayed wound healing, osteoporosis, elevated levels of SGPT and SAP, and vomiting and diarrhea (occasionally bloody). Cushings syndrome in dogs has been reported in association with prolonged or repeated steroid therapy. Possible increased susceptibility to bacterial invasion and/or the exacerbation of preexisting bacterial infection may occur in patients receiving corticosteroids. As noted above, however, this problem can be avoided by concomitant use of appropriate anti-infective agents. Possible side effects attributable to phenothiazine derivatives include sedation; protruding nictitating membrane; blood dyscrasias; intensification and prolongation of the action of analgesics, sedatives and general anesthetics; and potentiation of organophosphate toxicity and the activity of procaine hydrochloride.

It should be remembered that the premonitory signs of cortisone overdosage, such as sodium retention and edema, may not occur with prednisolone. Therefore, the veterinarians must be alert to detect less obvious side effects, such as blood dyscrasias, polydipsia, and polyuria.

The appearance and severity of side effects are dose related and are minimal at the recommended dosage level. If troublesome side effects are encountered, the dosage of Theralene Pectoral Nourrisson (Trimeprazine Tartrate) should be reduced and discontinued unless the severity of the condition being treated makes its relief paramount.

Prolonged treatment with Theralene Pectoral Nourrisson (Trimeprazine Tartrate) must be withdrawn gradually. Use of corticosteroids, depending on dose, duration, and specific steroid, may result in inhibition of endogenous steroid production following drug withdrawal. In patients presently receiving or recently withdrawn from systemic steroid treatments, therapy with a rapidly acting corticosteroid should be considered in unusually stressful situations.

DOSAGE AND ADMINISTRATION

The same dosage schedule may be followed for both antipruritic and antitussive therapy.

After 4 days, reduce dosage to 1/2 of the initial dose or to an amount just sufficient to maintain remission of symptoms. Individual animal response will vary and dosage should be adjusted until proper response is obtained.

Store in a Dry, Cool Place at Temperatures Not Above 25°C (77°F)

HOW SUPPLIED

100- and 1000-tablet bottles.

REFERENCES

• Knowles JO, Knowles RP: Preliminary reports on an effective antipruritic agent. Vet Med 55(8):67–68, 1960.
• Candlin FT: An agent to aid in control of pruritus. Vet Med 56(5):207–208, 1961.
• Yoxall AT, Hird JRF: Pharmacological Basis of Small Animal Medicine. Blackwell Scientific Publications, London, pp. 99–102, 1979.
• Booth N, McDonald LE: Veterinary Pharmacology and Therapeutics, 5th ed. Iowa State University Press, Ames, pp. 564–570, 1982.
• Davis L: Handbook of Small Animal Therapeutics. Churchill Livingstone, New York, pp. 140–142; 459–461; 468–469, 1985.
• Scott D: Systemic glucocorticoid therapy. Current Veterinary Therapy, Kirk WV Saunders, ed., Philadelphia, pp. 988–994, 1980.
• Lecture: "Rational Steroid Therapy" Duncan C. Ferguson, VMD, PhD, Department of Pharmacology, Cornell University.
• Kemppianen RJ, Lorenz MD, Thompson FN: Adrenocortical suppression in the dog given a single intramuscular dose of prednisolone or triamcinolone acetonide. Am J Vet Res 42(2):204–206, 1982.
• Rogers WA, Ruebner BH: A retrospective study of probable glucocorticoid induced hepatopathy in dogs. JAVMA 1977;170(6): 603-605.

NADA #12-437, Approved by FDA

Distributed by:

Zoetis Inc.

Kalamazoo, MI 49007

13846200

Revised: January 2013

Eye

Theralene Pectoral Nourrisson (Trimeprazine Tartrate) ^®

(trimeprazine with prednisolone)

Tablets

Antipruritic–Antitussive–

Anti-inflammatory

For use in dogs

Each tablet contains Theralene Pectoral Nourrisson (Trimeprazine Tartrate) tartrate

USP 10-[3-(Dimethylamino)-2-methylpropyl]-

phenothiazine tartrate (2:1) equivalent to

Theralene Pectoral Nourrisson (Trimeprazine Tartrate), 5 mg, and prednisolone, 2 mg.

Caution: Federal law restricts this drug to use

by or on the order of a licensed veterinarian.

100 tablets

NADA #12-437, Approved by FDA

zoetis

Theralene Pectoral Nourrisson (Trimeprazine Tartrate) ^®

(trimeprazine with prednisolone)

Tablets

Antipruritic–Antitussive–Anti-inflammatory

For use in dogs

Each tablet contains Theralene Pectoral Nourrisson (Trimeprazine Tartrate) tartrate USP 10-[3-(Di-

methylamino)-2-methylpropyl]-phenothiazine tartrate (2:1)

equivalent to Theralene Pectoral Nourrisson (Trimeprazine Tartrate), 5 mg, and prednisolone, 2 mg.

Caution: Federal law restricts this drug to use by or on

the order of a licensed veterinarian.

1000 tablets

NADA #12-437, Approved by FDA

zoetis