Hishiphagen

Glycyrrhizine, glycine, l-cysteine HCl.

Each ampoule (20 mL) contains: Monoammonium glycyrrhizinate 53 mg (equivalent to Glycyrrhizine 40 mg), Glycine 400 mg, L-Cysteine Hydrochloride Hydrate 22 mg (equivalent to L-Cysteine Hydrochloride 20 mg).

Improvement of abnormal hepatic function in chronic hepatic disease.
Eczema or dermatitis, urticaria, pruritus, drug eruption or toxicoderma, stomatitis, infant strophulus, phlycten.

The usual adult dosage for intravenous use is from 5 to 20 mL once a day. The dosage may be adjusted depending on the patient's age and symptoms.
For chronic hepatic disease, the daily dosage is from 40 to 60 mL once a day by intravenous injection or intravenous drip infusion. The dosage may be adjusted depending on the patient's age and symptoms. If an increased dosage is required, the daily dosage should be kept within the limit of 100 mL.

HISHIPHAGEN is contraindicated in the following patients: Patients with a history of hypersensitivity to any ingredients of HISHIPHAGEN; Patients with aldosteronism, myopathy, or hypokalemia. [Change for the worse if hypokalemia or hypertension may occur.]

Careful administration (HISHIPHAGEN should be administered with care in the following patients): Elderly patients [increased rate of hypokalemia] (see Use in Elderly as follows).
Important precautions: Thoroughly conduct interviews to predict occurrence of shocks.
Be prepared to provide emergency treatments in case shock occurs.
Maintain patient at rest after administration and carefully monitor the patient. HISHIPHAGEN should be administered with care when coadministered with products containing licorice because the overlap of glycyrrhizic acid contained in HISHIPHAGEN may cause pseudoaldosteronism.
Precautions concerning use: Rate of administration: Intravenous injections should be injected as slowly as possible while monitoring the patient.
Other precautions: Rhabdomyolysis has been reported in oral administration of products containing glycyrrhizic acid or licorice.
Use in Pregnancy & Lactation: HISHIPHAGEN should be used in patients that are pregnant or possibly pregnant only if the expected therapeutic benefits outweigh the possible risks. [Kidney malformation, etc., has been observed at massive doses of monoammonium glycyrrhizinate in animal studies (rats).]
Use in Elderly: HISHIPHAGEN should be used with caution while monitoring the patient. [In clinical experience, increased frequency of adverse reactions such as hypokalemia has been observed in elderly patients.]

HISHIPHAGEN should be used in patients that are pregnant or possibly pregnant only if the expected therapeutic benefits outweigh the possible risks. [Kidney malformation, etc., has been observed at massive doses of monoammonium glycyrrhizinate in animal studies (rats).]

No data has been obtained regarding frequency of adverse events due to HISHIPHAGEN.
Clinically significant adverse reactions (frequency not known): Shock, anaphylactic shock: Shock or anaphylactic shock (decreased blood pressure, loss of consciousness, dyspnea, cardiorespiratory arrest, flush, face oedema, etc.,) may occur. Carefully observe the patient, and if any abnormality is observed, HISHIPAGEN should be discontinued immediately and appropriate treatment instituted.
Anaphylactic reactions: Anaphylactic reactions (dyspnea, flush, face oedema, etc.) may occur. Carefully monitor the patient, and if any abnormality is observed. HISHIPHAGEN should be discontinued immediately and appropriate treatment instituted.
Pseudoaldosteronism: Increased dose or long-term use may cause such symptoms of pseudoaldosteronism as severe hypokalemia, increased frequency of hypokalemia, increased blood pressure, sodium/fluid retention, oedema, increased weight, etc. Carefully monitor the patient via measurement of serum potassium levels, and if any abnormality is observed, HISHIPHAGEN should be discontinued.
Feelings of weakness, muscular weakness, etc. may also occur as a result of hypokalemia.
Other adverse reactions: The following symptoms may occur, and increased dose may cause decreased serum. (See Table 1.)


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Precautions for Coadministration (HISHIPHAGEN should be administered with care when coadministered with the following drugs): (See Table 2.)


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Precautions for Handling: Plastic ampoules: Since an oxygen absorbent is enclosed to maintain stability of the product, do not remove the outer wrap until immediately before use. Use immediately after opening.
Do not use if there is any vapor inside the outer wrap, or if there is color, turbidity, or crystals in the liquid.
Stability testing: The results of a long-term storage test (25°C, 3 years) using the final container product showed that the appearance and strength are in compliance with the specification and that HISHIPHAGEN remains stable for 3 years under normal market conditions.

Store at temperature below 30°C.

Cholagogues, Cholelitholytics & Hepatic Protectors

A05BA - Liver therapy ; Used in liver therapy.

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