LACTULOSE- lactulose solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LACTULOSE (UNII: 9U7D5QH5AE) (LACTULOSE - UNII:9U7D5QH5AE)

Available from:

Fresenius Kabi Austria GmbH

INN (International Name):

LACTULOSE

Composition:

LACTULOSE 10 g in 15 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

For the prevention and treatment of portal-systemic encephalopathy, including the stages of hepatic pre-coma and coma. Controlled studies have shown that lactulose solution therapy reduces the blood ammonia levels by 25 to 50%; this is generally paralleled by an improvement in the patients' mental state and by an improvement in EEG patterns. The clinical response has been observed in about 75% of patients, which is at least as satisfactory as that resulting from neomycin therapy. An increase in patients' protein tolerance is also frequently observed with lactulose therapy. In the treatment of chronic portal-systemic encephalopathy, Lactulose has been given for over 2 years in controlled studies. Since lactulose solution contains galactose (less than 1.6 g/15 mL), it is contraindicated in patients who require a low galactose diet. Teratogenic Effects Pregnancy category B . Reproduction studies have been performed in mice, rats, and rabbits at doses up to 2 or 4 times the usual human oral dose and have revealed

Product summary:

Lactulose Solution USP, 10 g/15 mL, is a natural colored and an unflavored solution supplied in one pint (473 ml) bottles. Lactulose Solution contains lactulose 670 mg/mL (10 g/15 mL). Store between 36° to 86°F (2° to 30°C). Do not freeze. Under recommended storage conditions, a normal darkening of color may occur. Such darkening is characteristic of sugar solutions and does not affect therapeutic action. Prolonged exposure to temperatures above 86°F (30°C) or to direct light may cause extreme darkening and turbidity which may be pharmaceutically objectionable. If this condition develops, do not use. Prolonged exposure to freezing temperatures may cause change to a semi-solid, too viscous to pour. Viscosity will return to normal upon warming to room temperature. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure. Manufactured and packaged by: Fresenius Kabi Austria GmbH Estermannstraße 17 4020 Linz Austria Distributed by: Actavis Pharma, Inc. Parsipanny, NJ 07054 USA Revised - March 2016

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LACTULOSE - LACTULOSE SOLUTION
FRESENIUS KABI AUSTRIA GMBH
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(LACTULOSE SOLUTION, USP 10 G/15 ML)
1 INDICATIONS & USAGE
For the prevention and treatment of portal-systemic encephalopathy,
including the
stages of hepatic pre-coma and coma.
Controlled studies have shown that lactulose solution therapy reduces
the blood
ammonia levels by 25 to 50%; this is generally paralleled by an
improvement in the
patients' mental state and by an improvement in EEG patterns. The
clinical response has
been observed in about 75% of patients, which is at least as
satisfactory as that
resulting from neomycin therapy. An increase in patients' protein
tolerance is also
frequently observed with lactulose therapy. In the treatment of
chronic portal-systemic
encephalopathy, Lactulose has been given for over 2 years in
controlled studies.
2 DOSAGE & ADMINISTRATION
ORAL
Adult: The usual adult, oral dosage is 2 to 3 tablespoonfuls (30 to 45
mL, containing 20 g
to 30 g of lactulose) three or four times daily. The dosage may be
adjusted every day or
two to produce 2 or 3 soft stools daily.
Hourly doses of 30 to 45 mL of Lactulose may be used to induce the
rapid laxation
indicated in the initial phase of the therapy of portal-systemic
encephalopathy. When the
laxative effect has been achieved, the dose of lactulose may then be
reduced to the
recommended daily dose.
Improvement in the patient's condition may occur within 24 hours but
may not begin
before 48 hours or even later.
Continuous long-term therapy is indicated to lessen the severity and
prevent the
recurrence of portal-systemic encephalopathy. The dose of lactulose
for this purpose is
the same as the recommended daily dose.
PEDIATRIC: Very little information on the use of lactulose in young
children and
adolescents has been recorded. As with adults, the subjective goal in
proper treatment
is to produce 2 to 3 soft stools daily. On the basis of information
available, the
recommended initial daily oral dose in infants is 2.5 to 10 mL in
divided doses.
For older children and adol