TSUMURA Yokukansan extract granule  : 189 sachets
|Manufacturer||TSUMURA & CO.|
|Brand||TSUMURA & CO.|
|Shipping Schedule||about 3 weeks after payment|
Yokukansan extract granule  : 189 sachets
TJ-54 is indicated for the relief of the following symptoms of those patients with delicate co
nstitution and nervousness: Neurosis, insomnia, night cry in children, and peevishness in children.
Light grayish-brown Granules
7.5 g of TSUMURA Yokukansan extract granules (hereafter TJ-54)
contains 3.25 g of a dried extract of the following mixed crude drugs.
JP Atractylodes Lancea Rhizome ......4ｇ
JP Poria Sclerotium ............................4ｇ
JP Cnidium Rhizome ..........................3g
JP Uncaria Hook ...............................3g
JP Japanese Angelica Root .................3g
JP Bupleurum Root ............................2g
JP Glycyrrhiza ....................................1.5g
Parkinson's disease, Parkinson's syndrome
Sleep terror, night cry, tic disorder
The usual adult dose is 7.5 g/day orally in 2 or 3 divided doses before or between meals. The dosage may be adjusted ac-cording to the patient's age and body weight, and symptoms.
Kampo Granules : it can be taken with water, lukewarm water. Or taken like tea, dissolved with hot water.
1. Careful Administration (TJ-54 should be administered with care in the following patients.)
(1)Patients with an extremely weak gastrointestinal tract[Anorexia, epigastric distress, nausea, diarrhea, etc.
(2)Patients with anorexia, nausea or vomiting [These symptoms may be aggravated.]
2. Important Precautions
(1)When TJ-54 is used, the patient’s “SHO” (constitu-tion/symptoms) should be taken into account. The patient’s progress should be carefully monitored, and if no improvement in symptoms/findings is observed, continuous treatment should be avoided.
(2)SinceTJ-54 contains Glycyrrhiza, careful attention should be paid to the serum potassium level, blood pressure, etc., and if any abnormality is observed, ad-ministration should be discontinued.
(3)When TJ-54 is coadministered with other Kam-po-preparations (Japanese traditional herbal medi-cines), etc., attention should be paid to the duplication of the contained crude drugs.
SHO: The term “SHO” refers to a particular pathological status of a patient evaluated by the Kampo diagnosis, and is patterned according to the patient’s constitution, symp-toms, etc. Kampo-preparations (Japanese traditional herbal medicines) should be used afterconfirmation that it is suitable for the identified “SHO” of the patient.
3. Drug Interactions
Precautions for coadministration(TJ-54 should be ad-ministered with care when coadministered with the following drugs.)
(1) Preparations containing Glycyrrhiza
(2) Preparations containing Glycyrrhizinic acid or glycyrrhizinates
Signs, Symptoms, and Treatment
Pseudoaldosteronism is likely to occur. Besides, myopathy is likely to occur as a result of hypokale-mia.
Mechanism and Risk Factors
Since glycyrrhizinicacid has an accelerat-ing action on the po-tassium excretion at the renal tubules, ancceleration of de-crease in the serum potassium level has been suggested.
In a clinical survey of adverse reactions of 3,141 patientstreated with TJ-54 (October 2012 - March 2014), 162 ad-verse reactions including abnormal laboratory values were reported for 136 patients (4.3%).
Clinically ignificant adverse reactions
1) Interstitial pneumonia(incidence unknown):
If fever, cough, dyspnea, abnormal pulmonary sound, etc. are observed, administration of TJ-54 should be discontinued, and examinations such as X-ray or chest CT should be performed immediately and appropriate measures such as administration of adrenocortical hormones taken.
2) Pseudoaldosteronism(incidence unknown): Pseudoaldosteronism such as hypokalemia, in-creased blood pressure, retention of sodium/body fluid, edema, increased body weight, etc. may oc-cur. The patient should be carefully monitored (measurement of serum potassium level, etc.), and if any abnormality is observed, administration should be discontinued and appropriate measures such as administration of potassium preparations should be taken.
3) Heart failure (<0.1%): Heart failure may occur. Adequately monitor the patient, and discontinue administration and take appropriate measures if fluid buildup, rapid weight gain, and signs and
symptoms of heart failure (e.g., shortness of breath, increased cardiothoracic ratio, pleural effusion) are
4) Myopathy, rhabdomyolysis(incidence unknown): Myopathy and rhabdomyolysis may occur as a re-sult of hypokalemia. Adequately monitor the pa-tient, and discontinue administration and take ap-propriate measures such as administration of a po-tassium preparation if sluggishness, muscular weakness, myalgia, limb cramping/paralysis, ele-vated CK (CPK) levels, and elevated blood and urine myoglobin levels are observed.
5) Hepatic dysfunction and jaundice(incidence un-known): Hepatic dysfunction and/or jaundice with
remarkable elevation of AST (GOT), ALT (GPT), Al-P and γ-GTP etc. may occur.
The patient should be carefully monitored for abnormal find-ings. Administration should be discontinued and appropriate therapeutic measures should be taken, if abnormalities are observed.