Anti-allergic Drugs:

I. Scope: The monograph covers all oral preparations used for the temporary relief of the symptoms and allergy caused by allergic rhinitis, hay fever and allergy. The anti-allergic preparations covered in the monograph are those complying with the following conditions: A. Targeting the temporary relief of symptoms caused by allergic rhinitis and hay fever (stuffy nose, runny nose, sneezing, itchy eyes and throat) or any itchiness and rashes caused by allergies. B. Given orally. II. Active Ingredients: A. Types and content of active ingredients: 1. The active ingredients that can be allowed in use under the monograph are shown in table 1. 2. The upper limits of single dosage and daily dosage are set for the active ingredients in columns A, B and C of Table 1. 3. The upper and lower limits of the daily dosage are given for the active ingredients of items in column D of Table 1.

Table 1 Types of active ingredients

Column Item

Active Ingredient
Brompheniramine maleate Carbinoxamine maleate

Upper limit Upper limit of single of daily dosage (mg) dosage (mg)
4 4 25 4 16 16 75 16

Chlorcyclizine hydrochloride Chlorpheniramine maleate (dl-Chlorpheniramine maleate)

Table 1 Types of active ingredients (contd)

Column Item

Active

Upper limit Upper limit

Ingredient
Clemastine (fumarate) Dexbrompheniramine maleate Dexchlorpheniramine maleate (d-Chlorpheniramine maleate) Diphenhydramine hydrochloride Diphenhydramine salicylate

of single of daily dosage (mg) dosage (mg)

1Base 2 2 25-50 25 4 4 25 25 25 2.5 20 10 25 60 60 50 50 2-12 2Base 8 8 150 75 12 16 100 100 100 10 60 40 100 240 240 150 150

Diphenylpyraline hydrochloride Isothipendyl hydrochloride Phenindamine tartrate Pheniramine maleate Pyrilamine maleate Triprolidine hydrochloride dl-Methylephedrine hydrochloride Phenylephrine hydrochloride

Phenylpropanolamine hydrochloride Pseudoephedrine hydrochloride Pseudoephedrine sulfate Caffeine Caffeine anhydrous

C Column Item

Type
Vitamin B2 Riboflavin (Vitamin B2) Riboflavin butyrate Active Ingredient Riboflavin sodium phosphate Vitamin B6

Daily Dosage (mg)

5-50

2 3 4 5 6

Pyridoxine hydrochloride Active Ingredient (Vitamin B6) Biotin Calcium pantothenate Niacinamide (Nicotinamide) 0.01-0.50 5-30 12-60 60-200

Orotic acid B. Combination rules (see Table 2): 1. Products used for relief symptoms of rhinitis:

a) Mandatory ingredients: refer to the active ingredients in Columns A and B of Table 1. Formulation should contain each one active ingredient from Column A and B. b) Optional ingredients: refer to the active ingredients shown in Column C of Table 1. Not more than one ingredient from Column C is allowed to be used with the mandatory ingredients. The combination is optional. 2. Products used for relief symptom of general allergy: a) Mandatory ingredients: refer to the active ingredients shown in Column A of Table 1. The formulation must contain one mandatory ingredient. b) Optional ingredients: refer to the active ingredients shown in Column D of Table 1. The combination should supported by the reference formula approved at least in one of the ten advanced countries when submission. 3. Clemastine (fumarate) (Column A of Table 1) limited to a single preparation. C. Dosage Limitation in combinations (see Table 2): 1. The unit dosage for each ingredient should not exceed the upper limit of single dosage set in Table 1. 2. The combination coefficient for ingredients of Column A of Table 1, should be between 0.5 and 1.
Daily dose of ingredient in Column A combination coefficient = Max. dose of the ingredient in Column A

3. When a formula contains an ingredient from columns B or C, the combination coefficient should be between 1.0 and 0.2.
Daily dose of ingredient in Column B (or C) combination coefficient = Max. dose of the ingredient in Column B (or C)

4. When a formula contains ingredients from Column D of Table 1,: a. The upper and lower limits of the daily dosage for ingredients in column D are as per Table 1. b. While a formula contains two or more ingredients from the Item 1 in Column D, the combination coefficient cannot exceed 1.0. The combination coefficient results from the two steps: i. There are more than two ingredients from Item 1 of Column D. For each ingredient, the daily dose of the used ingredient divided by the maximum daily

dose of the used ingredient gives the each outcome. ii. To sum up the outcomes to obtain the combination coefficient and the number cannot exceed 1.0.

Table 2: Combination rules and coefficient

Combination rules Preparation Active Ingredient

Combination coefficient Remarks

Same type General Same type component Rhinitis anti- component mixed with drugs allergic mixed with at least two drugs one kind kinds
1 1/2

Column A

Anti-histamine

One ingredient from this column is a must. Clemastinefumarateis limited as a single preparation It is a must for products used for relief the symptom of rhinitis to contain one ingredient from this column. Not more than one ingredient is allowed to be used in the combiantion
1

Column B Column C

Adrenergic

1 1/5

Caffeine-type

1 1/5

Item 1 Vitamin B2

Complies with Table 1 Complies with Table 1 Complies with Table 1 Complies with Table 1 Complies with Table 1 Complies with Table 1

Item 2 Vitamin B6

Item 3 Biotin Column D Item 4 Niacinamide

Complies with Table 1 the dose should follow the upper and lower limitation set in Table 1

Item 5 Orotic acid Calcium pantothenate

Item 6

Mandatory formula component Optional formula component Components cannot be used in the combination

III. Dosage forms Restricted to, tablets, film coated tablets, sugar-coated tablets, capsules, soft capsules, oral liquids, medicinal syrups, powders, liquid dissolvable powders, syrup dissolvable powders, oral granules, syrup granules and fine granules. IV. Indications Clinical indications differ depending on the mandatory combination components.

Preparations

Mandatory combination components

Indications

Rhinitis drugs

Columns A and B

Relief of symptoms caused by allergic rhinitis and hay fever (stuffy nose, runny nose, sneezing, itchy eyes and throat). Relief of symptoms caused by allergic rhinitis and hay fever (, runny nose, sneezing, itchy eyes and throat), and itches and rashes caused by allergies.

General antiallergic drugs

Column A

V. Usage and dosage A. Take every four hours, 3 to 4 per day. B. For, Clemastine (fumarate) in Column A of Table 1, take twice daily. C. For oral liquid medicines (including syrups), a single adult dose must be at least 5mL. The largest retail unit packaging must not exceed 3 days usage.

D. Age distribution coefficient: 12 years old and above, use adult dosage 6-12 years old, use of adult dosage 3-6 years old, use of adult dosage Less than 3 years old, consult a physician before using VI. Precaution A. Keep the drugs out of the reach of children. B. Store in a cool and dry place, avoiding direct sunlight. C. This medication should not be taken by either pregnant or breastfeeding women, except on advice by a physician or pharmacist. D. Do not exceed the recommended dosage. If adverse effects occur, stop taking the medication immediately and seek medical advice. E. Shake the container well before using liquid medicines and use the device supplied by the manufacturer for administrating the medicine. VII. Warnings A. This medicine may cause drowsiness, dry mouth, vision difficulties and occasional excitability (more commonly in children and the elderly). B. Persons suffering from serious metabolic hepatic or kidney disease should not take this medication, unless prescribed by a physician. C. This medication should not be taken by those who have previously shown allergic reaction towards it, unless on advice by a physician or pharmacist. D. This medication should not be taken by those previously having had cardiac function obstruction, high blood pressure, diabetes, hyperthyroidism or kidney function obstruction, unless on advice by a physician or pharmacist,. E. This medicine should be taken with care by the elderly and should not be taken by infants under three years of age. F. This medication should not be taken by anyone suffering from breathing disorders, chronic bronchitis, glaucoma, pulmonary emphysema, chronic lung disease, shortness of breath, breathing difficulties or urinary problems stemming from a swollen prostate. G. This medication should not be taken with alcoholic beverages. H. This medication should not be taken together with sedatives or tranqulizers, unless on advise by a physician or pharmacist, I. This medication may cause drowsiness. Do not drive a vehicle or operate machinery after taking.

J. If the symptoms have not improved after taking this medication for several days, stop taking this medication and consult a physician. K. This medication should not be taken together with other oral preparations containing anti-histamine or nasal decongestants (e.g. cold medicine, cough expectorant, motion sickness drugs, sinus medication or anti-allergic drugs, etc.). L. For preparations containing Clemastine (fumurate), add the following stipulation: Please consult a physician before giving to children under 12 years old. M. For preparations containing Triprolidine hydrochloride, add the following stipulation: This medicine contains Triprolidine hydrochloride. Please consult a physician before giving to children under six years old. N. For preparations containing nasal decongestants Phenylephrine hydrochloride, Pseudoephedrine hydrochloride or Pseudoephedrine sulfate, add the following warnings: This medicine contains (ingredient name). Please note the following: 1. This medicine should not be taken by those suffering from cardiac disease, high blood pressure, hyperthyroidism, diabetes or urinary problems caused by a swollen prostrate, unless on advice by a physician or pharmacist. 2. This medicine should not be used while taking monoamine oxidase inhibitor (MAOI), or within two weeks of ending a course of MAOI. If you are uncertain as to whether the medicine you are taking contains MOAI, please consult a physician or pharmacist. O. For preparations containing the nasal decongestants phenylpropanolamine hydrochloride, add the following warnings: This medicine contains phenylpropanolamine hydrochloride. Please note the following: 1. This medicine should not be taken by children aged 12 years or under. 2. This medicine should be used in strict accordance with the recommended dosage, with each dosage not exceeding 25mg and the daily dosage not exceeding 100mg. Exceeding the recommended dosage can cause rapid heart rate, pupil dilation, excitability and irregular heartbeat. There have been cases of heart disease, stroke, intracranial hemorrhage, brain hemorrhage and even death. 3. Ifnervousness, dizziness, sleeplessness, rapid heartbeat, headache, etc, occur, stop taking this medicine and consult a physician.

4. This medicine should not be taken during treatment for high blood pressure, depression, dietary imbalance, cardiac disease, diabetes, thyroid disease or enlarged prostate unless under a physicians supervision. 5. Do not use this medicine when on a course of any allergy, asthma, cough or cold medicine or nasal decongestants containing the following active agents found in this medicine - Phenylpropanolamine hydrochloride, Phenylephrine, Pseudoephedrine or Ephedrine, 6. Do not take this medicine if you are taking any other prescription drugs, unless on advice by a physician. 7. Do not take this medicine when on a course of monoamine oxidase inhibitor (MAOI), or within two weeks of stopping a course of MAOI. P. For preparations containing caffeine, add the following warning: This medicine contains caffeine. You should restrict the further intake of medicines or beverages containing caffeine (e.g. tea, coffee, cola, etc.). Excess intake of caffeine can cause anxiety, excitability and sleeplessness as well as rapid heartbeat.