PACKAGE INSERT

A Comprehensive Guide for Pharmacy Students

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 Key information in the PIs
• Indications and Use
• Dosage and Administration
• Contraindications
• Warnings and Precautions
• Adverse Reactions
• Drug Interactions
• Storage and handling

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 Indications and Use
• Describe the conditions the medication treats

• Explain when the medication should be used

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 Indications and Use
§ Antacids
§ Antidiarrheals
§ Antiemetic
§ Antispasmodics
§ Histamine-2 (H2) Blockers
§ Laxatives
§ Proton Pump inhibitors
§ Analgesic /ˌæn.əlˈdʒiː.zɪk/
§ Antibiotics
§ Anesthetic /ˌæn.əsˈθet.ɪk/
§ Antiretrovirals
§ Antipyretic /ˌæntipaɪˈretɪk/
§ Antihistamines
§ Sedative /ˈsed.ə.tɪv/
§ Antitussives
§ Disinfectants /ˌdɪs.ɪnˈfek.tənt/
§ Bronchodilators
§ Antiseptics /ˌæn.tiˈsep.tɪk/
§ Corticosteroids
§ Diuretics
§ Decongestants
§ Anticoagulants
§ Expectorants
§ Antidepressants 17
 Dosage and Administration
• Recommended Dosages

• Route of Administration

• Dosage forms

• Frequency

• Speacial Instructions (with or without food)

• Dosage Adjustment Considerations

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 Dosage and Administration
Route of Route Meaning Abbreviation
Oral By mouth PO, p.o.
Administration
Buccal Inside the cheek buc
Sublingual Under the tongue Subling, subl, SL
Rectal By rectum R
Intradermal Into the skin ID
Intramuscular Into the muscle IM
Intravenous Into the vein IV
Subcutaneous Under skin (into fatty layer) Subcut, Subq.
Topical On the skin -
Inhalation Into the nose, throat and lungs
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 Dosage and Administration
Route of Administration

Oral (Under the tongue) (Inside the cheek) Rectal

(By mouth) (By rectum)
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 Dosage and Administration
Route of Administration

Into the vein

(Into the skin) (Into the vein)

(Under skin) (Into the muscle)

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 Dosage and Administration
Route of Administration

Inhalational Topical
(Into the nose, throat and lungs) (On the skin)
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 Dosage and Administration
§ Tablet § Drops § Ointment
§ Effervescent tablet (eye drops, ear drops) § Gel
§ Chewable tablet § Syrup § Cream
§ Film-coated tablet § Emulsion § Suppository
Dosage forms
§ Lozenge § Suspension § Ovule
§ Hard-shelled capsule
§ Soft-shelled capsule
§ Powder
§ Granule 23
 Dosage and Administration

Dosage forms

Tablets Effervescents Lozenges /ˈlɒz.ɪndʒ/

Hard-shelled capsules Soft-shelled capsules Powder

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https://www.fda.gov/industry/structured-product-labeling-resources/dosage-forms
 Dosage and Administration
Dosage forms

Syrup Ear drops

Solution Emulsion Suspension Eye drops Nasal drops 26

 Dosage and Administration

Dosage forms

Gel Ointment

Transdermal patch Cream 27

 Dosage and Administration

Suppositories Enemas Ovules

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Dosage and Administration

Inhalers Nebulizers
/ɪnˈheɪ.lər/ /ˈneb.jə.laɪ.zər/
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 Dosage and Administration
Frequency § Once a day (OD)
§ Twice a day (BID)
§ Three times a day (TID)
§ Four times a day (QID)
§ Every four/six/eight hours
§ Before bed
§ Every other day
§ As needed (when necessary)
§ Before/after meals
§ Weekly (once a week) 30
 Contraindications
• List conditions or situations in which the medication should be not used

• Medical conditions or Patient Populations to Avoid

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 Warnings and Precautions
• Hight light potential risks or precautions associated with the medication

• Mention patient groups that might need special consideration

• Pregnancy /ˈpreɡ.nən.si/
• Lactation /lækˈteɪ.ʃən/

• Pediatric /ˌpiː.diˈæt.rɪks/
• Geriatric /ˌdʒer.iˈæt.rɪk/

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 Warnings and Precautions
Giving General Advice
• Mensamint may cause dizziness.
• Mensamint can interact with other
medicines.
• Like all drugs, this medicine can cause
side effects.
• Use Mensamint with caution while
driving or undertaking dangerous
activities.
• It is possible that you may receive this
medicine, or an alternative may be used.
Giving Strong warnings
• Do not use/take Mensamint if…
• Stop using and ask the doctor if…
• Keep out of reach of children.
• Tell your doctor
immediately/right away if….
• You must not drive while taking
this drug.
• You should not take Mensamint if
you have a history of….
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 Side Effects
• List common and Serious Side Effects

• How to Manage Side Effects

• Include information about when to seed medical attention

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 Side effects
• Nausea
• Headache • Palpitations
• Vomiting
• Dizziness • Hypotension/Hypertension
• Diarrhea
• Drowsiness • Changes in Menstrual Cycle
• Constipation
• Abdominal Pain • Coughing • Fertility Impact
• Indigestion • Shortness of Breath • Breast Changes
• Gastric Irritation • Wheezing • Semen Quality
• Gastroesophageal Reflux Disease • Nasal Congestion • Birth Defects
(GERD)
• Respiratory Tract Infections • Testosterone Impact
• Loss of Appetite
• Bloating • Nasal Irritation • Sexual Dysfunction
• Flatulence • Throat Irritation
• Gastrointestinal Ulcers 35
 Drug Interactions
• Explain potential interactions with other medications, foods, or
substances.

• Emphasize the importance of informing healthcare providers about all

medications being taken.

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 Storage and handling
• Provide instructions for proper storage conditions (temperature, light, moisture)

• Advise against storing medications in inappropriate places (bathroom)

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 Storage and handling
Packaging

Ampoule
Prefilled Syringe Sachet

Blister pack Strip pack 38

 Patient counseling information
• Suggest key points for pharmacists to discuss with patients

• Advice on missed doses, overdose

• What to do in case of adverse effects

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 References
1. https://www.fda.gov/drugs/fdas-labeling-resources-human-
prescription-drugs/patient-labeling-resources#medication-guides
2. https://www.fda.gov/drugs/information-consumers-and-patients-
drugs/otc-drug-facts-label
3. https://www.ema.europa.eu/en/human-regulatory/marketing-
authorisation/product-information/how-prepare-review-summary-
product-characteristics
4. https://www.medicines.org.uk/emc
5. https://dailymed.nlm.nih.gov/dailymed/
6. https://www.ema.europa.eu/en
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