Online PLR Articles Directory Virginia: October 2016

Tuesday, October 4, 2016

Prostin E2

dinoprostone

Dosage Form: Vaginal Suppository

Prostin E2 Description

Prostin E2 Vaginal Suppository, an oxytocic, contains dinoprostone as the naturally occurring prostaglandin E2 (PGE2).

Its chemical name is (5Z,11α,13E,15S)-11,15-Dihydroxy-9-oxo-prosta-5,13-dien-1-oic acid and the structural formula is represented below:

The molecular formula is C20H32O5. The molecular weight of dinoprostone is 352.5. Dinoprostone occurs as a white crystalline powder. It has a melting point within the range of 64° to 71°C. Dinoprostone is soluble in ethanol and in 25% ethanol in water. It is soluble in water to the extent of 130 mg/100 mL.

Each suppository contains 20 mg of dinoprostone in a mixture of glycerides of fatty acids.

Prostin E2 - Clinical Pharmacology

Prostin E2 Vaginal Suppository administered intravaginally stimulates the myometrium of the gravid uterus to contract in a manner that is similar to the contractions seen in the term uterus during labor. Whether or not this action results from a direct effect of dinoprostone on the myometrium has not been determined with certainty at this time. Nonetheless, the myometrial contractions induced by the vaginal administration of dinoprostone are sufficient to produce evacuation of the products of conception from the uterus in the majority of cases.

Dinoprostone is also capable of stimulating the smooth muscle of the gastrointestinal tract of man. This activity may be responsible for the vomiting and/or diarrhea that is not uncommon when dinoprostone is used to terminate pregnancy.

In laboratory animals, and also in man, large doses of dinoprostone can lower blood pressure, probably as a consequence of its effect on the smooth muscle of the vascular system. With the doses of dinoprostone used for terminating pregnancy this effect has not been clinically significant. In laboratory animals, and also in man, dinoprostone can elevate body temperature. With the clinical doses of dinoprostone used for the termination of pregnancy some patients do exhibit temperature increases.

Indications and Usage for Prostin E2

Prostin E2 Vaginal Suppository is indicated for the termination of pregnancy from the 12th through the 20th gestational week as calculated from the first day of the last normal menstrual period.

Prostin E2 is also indicated for evacuation of the uterine contents in the management of missed abortion or intrauterine fetal death up to 28 weeks of gestational age as calculated from the first day of the last normal menstrual period.

Prostin E2 is indicated in the management of nonmetastatic gestational trophoblastic disease (benign hydatidiform mole).

Contraindications

Hypersensitivity to dinoprostone

Acute pelvic inflammatory disease

Patients with active cardiac, pulmonary, renal, or hepatic disease

WARNINGS

Dinoprostone, as with other potent oxytocic agents, should be used only with strict adherence to recommended dosages. Dinoprostone should be used by medically trained personnel in a hospital which can provide immediate intensive care and acute surgical facilities.

Dinoprostone does not appear to directly affect the fetoplacental unit. Therefore, the possibility does exist that the previable fetus aborted by dinoprostone could exhibit transient life signs. Dinoprostone is not indicated if the fetus in utero has reached the stage of viability. Dinoprostone should not be considered a feticidal agent.

Evidence from animal studies has suggested that certain prostaglandins may have some teratogenic potential. Therefore, any failed pregnancy termination with dinoprostone should be completed by some other means.

Prostin E2 Vaginal Suppository should not be used for extemporaneous preparation of any other dosage form.

Neither the Prostin E2 Vaginal Suppository, as dispensed nor any extemporaneous formulation made from the Prostin E2 Vaginal Suppository should be used for cervical ripening or other indication in the patient with term pregnancy.

Precautions

1. General precautions

Animal studies lasting several weeks at high doses have shown that prostaglandins of the E and F series can induce proliferation of bone. Such effects have also been noted in newborn infants who have received prostaglandin E1 during prolonged treatment. There is no evidence that short term administration of Prostin E2 Vaginal Suppository can cause similar bone effects.

As in spontaneous abortion, where the process is sometimes incomplete, abortion induced by Prostin E2 may sometimes be incomplete. In such cases, other measures should be taken to assure complete abortion.

In patients with a history of asthma, hypo-or hypertension, cardiovascular disease, renal disease, hepatic disease, anemia, jaundice, diabetes or history of epilepsy, dinoprostone should be used with caution.

Dinoprostone administered by the vaginal route should be used with caution in the presence of cervicitis, infected endocervical lesions, or acute vaginitis.

As with any oxytocic agent, dinoprostone should be used with caution in patients with compromised (scarred) uteri.

Dinoprostone vaginal therapy is associated with transient pyrexia that may be due to its effect on hypothalamic thermoregulation. In the patients studied, temperature elevations in excess of 2°F (1.1°C) were observed in approximately one-half of the patients on the recommended dosage regimen. In all cases, temperature returned to normal on discontinuation of therapy. Differentiation of post-abortion endometritis from drug-induced temperature elevations is difficult, but with increasing clinical exposure and experience with PGE2 vaginal therapy the distinctions become more obviously apparent and are summarized below:

	Endometritis pyrexia	PGE2 induced pyrexia
a.	Time of onset: Typically, on third post-abortional day (38°C or higher).	Within 15–45 minutes of suppository administration.
b.	Duration: Untreated pyrexia and infection continue and may give rise to other infective pelvic pathology.	Elevations revert to pretreatment levels within 2–6 hours after discontinuation of therapy or removal of suppository from vagina without any other treatment.
c.	Retention: Products of conception are often retained in the cervical os or uterine cavity.	Elevation occurs irrespective of any retained tissue.
d.	Histology: Endometrium shows evidence of inflammatory lymphocytic infiltration with areas of necrotic hemorrhagic tissue.	Although the endometrial stroma may be edematous and vascular, there is relative absence of inflammatory reaction.
e.	The uterus: Often remains boggy and soft with tenderness over the fundus, and pain on moving the cervix, on bimanual examination.	Normal uterine involution not tender.
f.	Discharge: Often associated foul-smelling lochia and leukorrhea.	Lochia normal.
g.	Cervical culture The culture of pathological organisms from the cervix or uterine cavity after abortion does not, of itself, warrant the diagnosis of septic abortion in the absence of clinical evidence of sepsis. It is not uncommon to culture pathogens from cases of recent abortion not clinically infected. Persistent positive culture with clear clinical signs of infection are significant in the differential diagnosis.
h.	Blood count Leukocytosis and differential white cell counts are not of major clinical importance in distinguishing between the two conditions, since total WBC's may be increased as a result of infection and transient leukocytosis may also be drug induced.

In the absence of clinical or bacteriological evidence of intrauterine infection, supportive therapy for drug induced fevers includes the forcing of fluids. As all PGE2-induced fevers have been found to be transient or self-limiting, it is doubtful if any simple empirical measures for temperature reduction are indicated.

2. Laboratory tests

When a pregnancy diagnosed as missed abortion is electively interrupted with intravaginal administration of dinoprostone, confirmation of intrauterine fetal death should be obtained in respect to a negative pregnancy test for chorionic gonadotropic activity (U.C.G. test or equivalent). When a pregnancy with late fetal intrauterine death is interrupted with intravaginal administration of dinoprostone, confirmation of intrauterine fetal death should be obtained prior to treatment.

3. Drug interactions

Prostin E2 may augment the activity of other oxytocic drugs. Concomitant use with other oxytocic agents is not recommended.

4. Carcinogenesis, mutagenesis, impairment of fertility

Carcinogenic bioassay studies have not been conducted in animals with Prostin E2 due to the limited indications for use and short duration of administration. No evidence of mutagenicity was observed in the Micronucleus Test or Ames Assay.

5. Pregnancy

Teratogenic Effects: Pregnancy Category C

Animal studies do not indicate that Prostin E2 is teratogenic, however, it has been shown to be embryotoxic in rats and rabbits and any dose which produces increased uterine tone could put the embryo or fetus at risk. See WARNINGS section.

6. Pediatric use

Safety and effectiveness in pediatric patients have not been established.

Adverse Reactions

The most frequent adverse reactions observed with the use of dinoprostone for abortion are related to its contractile effect on smooth muscle.

In the patients studied, approximately two-thirds experienced vomiting, one-half temperature elevations, two-fifths diarrhea, one-third some nausea, one-tenth headache, and one-tenth shivering and chills.

In addition, approximately one-tenth of the patients studied exhibited transient diastolic blood pressure decreases of greater than 20 mmHg.

Two cases of myocardial infarction following the use of dinoprostone have been reported in patients with a history of cardiovascular disease.

It is not known whether these events were related to the administration of dinoprostone.

Adverse effects in decreasing order of their frequency, observed with the use of dinoprostone, not all of which are clearly drug related include:

Vomiting

Diarrhea

Nausea

Fever

Headache

Chills or shivering

Backache

Joint inflammation or pain new or exacerbated

Flushing or hot flashes

Dizziness

Arthralgia

Vaginal pain

Chest pain

Dyspnea

Endometritis

Syncope or fainting sensation

Vaginitis or vulvitis

Weakness

Muscular cramp or pain

Tightness in chest

Nocturnal leg cramps

Uterine rupture

Breast tenderness

Blurred vision

Coughing

Rash

Myalgia

Stiff neck

Dehydration

Tremor

Paresthesia

Hearing impairment

Urine retention

Pharyngitis

Laryngitis

Diaphoresis

Eye pain

Wheezing

Cardiac arrhythmia

Skin discoloration

Vaginismus

Tension

Prostin E2 Dosage and Administration

STORE IN A FREEZER NOT ABOVE −20°C (−4°F) BUT BRING TO ROOM TEMPERATURE JUST PRIOR TO USE.

REMOVE FOIL BEFORE USE.

A suppository containing 20 mg of dinoprostone should be inserted high into the vagina. The patient should remain in the supine position for ten minutes following insertion.

Additional intravaginal administration of each subsequent suppository should be at 3- to 5-hour intervals until abortion occurs. Within the above recommended intervals administration time should be determined by abortifacient progress, uterine contractility response, and by patient tolerance. Continuous administration of the drug for more than 2 days is not recommended.

How is Prostin E2 Supplied

Prostin E2 Vaginal Suppositories are available in foil strips of 5 individually sealed suppositories, NDC 0009-0827-03. Each suppository contains 20 mg of dinoprostone in a mixture of glycerides of fatty acids.

STORE IN A FREEZER NOT ABOVE −20°C (−4°F).

Rx only

LAB-0063-2.0

Prostin E2
dinoprostone suppository

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	0009-0827
Route of Administration	VAGINAL	DEA Schedule

INGREDIENTS
Name (Active Moiety)	Type	Strength
dinoprostone (dinoprostone)	Active	20 MILLIGRAM In 1 SUPPOSITORY
glycerides of fatty acids	Inactive

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0009-0827-03	5 SUPPOSITORY In 1 CARTON	None

Revised: 05/2006Pharmacia and UpJohn Company

More Prostin E2 resources

Prostin E2 Side Effects (in more detail)
Prostin E2 Use in Pregnancy & Breastfeeding
Prostin E2 Drug Interactions
Prostin E2 Support Group
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Prostin E2 Concise Consumer Information (Cerner Multum)

Prostin E2 Advanced Consumer (Micromedex) - Includes Dosage Information

Cervidil Inserts MedFacts Consumer Leaflet (Wolters Kluwer)

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Compare Prostin E2 with other medications

Abortion
Labor Induction
Trophoblastic Disease

Protopic topical

Generic Name: Tacrolimus topical
Class: Skin and Mucous Membrane Agents, Miscellaneous
Chemical Name: [3S - [3R*[E(1S*,3S*,4S*)],4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]] - 5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a - hexadecahydro - 5,19 - dihydroxy - 3 - [2 - (4 - hydroxy - 3 - methoxycyclohexyl) - 1 - methylethenyl] - 14,16 - dimethoxy - 4,10,12,18 - tetramethyl - 8 - (2 - propenyl) - 15,19 - epoxy - 3H - pyrido[2,1 - c][1,4]oxaazacyclotricosine - 1,7,20,21(4H,23H) - tetrone, monohydrate
CAS Number: 109581-93-3

Long-term safety of topical tacrolimus not established.^a ^c

Malignancies (e.g., skin cancers, lymphoma) reported rarely in patients treated with topical calcineurin inhibitors, including tacrolimus; causal relationship not established.^a ^c

Avoid continuous long-term use of topical tacrolimus; limit application to areas affected by atopic dermatitis.^a ^c (See Carcinogenicity under Cautions.)

Topical tacrolimus is not indicated for use in children <2 years of age; only the 0.03% ointment is indicated for use in children 2–15 years of age.^a ^c

Introduction

Immunosuppressive agent; macrolide produced by Streptomyces tsukubaensis.¹

Uses for Protopic

Atopic Dermatitis

Second-line therapy for short-term and noncontinuous chronic treatment of moderate to severe atopic dermatitis (eczema) in immunocompetent adults and children 2–15 years of age who are unable to tolerate or have not responded to first-line therapies or for whom first-line therapies are inadvisable.⁴ ⁶ ⁷ ⁸ ¹³ ¹⁴ ^a (See Carcinogenicity under Cautions.)

Not indicated for use in children <2 years of age.^a ^c

Protopic Dosage and Administration

Administration

Topical Administration

Apply topically to the skin as a 0.03 or 0.l% ointment.^a

For external use only; do not use in the eyes or ingest.^a

Apply in thin layers;¹ rub gently and completely into affected areas of skin.¹

Use minimum amount required to control symptoms;¹² ^a ^b limit application to areas affected with atopic dermatitis.^a ^b (See Carcinogenicity under Cautions.)

Use with caution on the face or neck, large areas of the body (i.e., >50% of the total body surface area), or areas of broken skin.³ ¹¹ (See Absorption under Pharmacokinetics.)

Do not use occlusive dressings or wrappings.¹ ⁹

Dosage

Pediatric Patients

Atopic Dermatitis

Topical

Children 2–15 years of age: Apply 0.03% ointment to affected areas twice daily,¹ ⁹ approximately 12 hours apart.⁹

Adolescents ≥16 years of age: Apply 0.03 or 0.l% ointment to affected areas twice daily,¹ ⁹ ^b approximately 12 hours apart.⁹

Discontinue treatment following resolution of signs and symptoms (e.g., pruritus, rash, erythema).^a ^b If manifestations persist beyond 6 weeks, reexamine patient and confirm diagnosis.^a

Adults

Atopic Dermatitis

Topical

Apply 0.03 or 0.l% ointment to affected areas twice daily,¹ ⁹ approximately 12 hours apart.⁹

Discontinue treatment following resolution of signs and symptoms (e.g., pruritus, rash, erythema).^a ^b If manifestations persist beyond 6 weeks, reexamine patient and confirm diagnosis.^a

Prescribing Limits

Pediatric Patients

Atopic Dermatitis

Topical

For short-term and intermittent use only; avoid continuous long-term use.¹² ^a Safety of noncontinuous use for >1 year not established.¹² ^a ^c (See Carcinogenicity under Cautions.)

Adults

Atopic Dermatitis

Topical

For short-term and intermittent use only; avoid continuous long-term use.¹² ^a Safety of noncontinuous use for >1 year not established.¹² ^a ^c (See Carcinogenicity under Cautions.)

Special Populations

Hepatic Impairment

No dosage adjustment appears necessary; effect of hepatic impairment on the pharmacokinetics of topical tacrolimus has not been evaluated.^a

Renal Impairment

No dosage adjustment appears necessary.^a Effect of renal impairment on the pharmacokinetics of topical tacrolimus has not been evaluated;^a following IV administration of tacrolimus, elimination in patients with renal dysfunction is similar to that in healthy individuals.^a

Cautions for Protopic

Contraindications

Known hypersensitivity to tacrolimus or any ingredient in the formulation.¹

Warnings/Precautions

Warnings

Carcinogenicity

Possible increased risk of malignancies.¹² ¹³ ¹⁴ ^a (See Boxed Warning.)

Malignancies (including lymphoma and skin cancers) reported rarely in children and adults receiving topical tacrolimus.¹² ¹³ ¹⁴ ^a Concerns also based on case reports of malignancies (including lymphoma and skin cancers) in patients (including transplant patients) receiving prolonged systemic therapy with calcineurin inhibitors (e.g., cyclosporine, tacrolimus);^a animal studies indicating dose-related increases in the risk of lymphoma and other malignancies (particularly of the skin) with tacrolimus and other calcineurin inhibitors, possibly due to immunosuppression;¹ ¹⁰ ¹¹ ¹² ¹³ ¹⁴ ^a and known pharmacologic effects of these immunosuppressants.^a ¹² ¹³ ¹⁴

Systemic administration of tacrolimus in kidney and liver transplant patients is associated with development of lymphoma and skin cancers.¹³ ¹⁴ ^a Risk appears to be related to dose and duration of exposure.¹³ ¹⁴

Tacrolimus may be absorbed into systemic circulation following topical application, but concentrations generally are very low.¹⁴ ^a The lowest blood tacrolimus concentration associated with systemic effects (e.g., immunosuppression) has not been determined.^a (See Absorption under Pharmacokinetics.)

Risk associated with systemic therapy is related to intensity and duration of immunosuppression.^a The potential for systemic immunosuppression with topical tacrolimus and the drug’s role in the development of malignancies in humans have not been established.¹² ¹³ ¹⁴ ^a Long-term studies in humans are needed to determine whether topical tacrolimus is associated with an increased risk of malignancies.¹² ¹³ Until such data are available, FDA recommends limiting use to the labeled indication, reserving the drug for use as a second-line agent for short-term and intermittent treatment.¹² ¹³ (See Atopic Dermatitis under Uses, see Immunocompromised Patients under Cautions, and see Dosage and Administration.) Carefully evaluate potential risks and benefits of therapy.¹² ¹³

Avoid use for malignant or premalignant skin conditions (e.g., cutaneous T-cell lymphoma [CTCL]), which may appear clinically similar to dermatitis.^a

General Precautions

Lymphadenopathy

Lymphadenopathy reported; usually related to infections and resolves following appropriate anti-infective therapy.¹ Also reported in association with malignancy.¹⁴ Investigate etiology if lymphadenopathy develops.¹ Discontinue tacrolimus in the absence of a clear etiology or in the presence of acute infectious mononucleosis.^a Monitor patients with lymphadenopathy to ensure that it resolves.¹

Netherton’s Syndrome

Not recommended for use in patients with Netherton’s syndrome because of the potential for increased systemic absorption of tacrolimus.¹

Generalized Erythroderma

Safety in patients with generalized erythroderma has not been established.¹

Dermatologic Reactions

Possible burning sensation (burning, stinging, soreness) or pruritus at the treatment site within the first few days of initiating therapy.¹ Reactions usually improve as the lesions of atopic dermatitis resolve.¹

Infectious Complications

Clinical infections (e.g., bacterial, viral) at treatment sites should be cleared before initiating tacrolimus therapy.¹ ^a Safety and efficacy not established for treatment of clinically infected atopic dermatitis.¹

Possible increased risk of varicella-zoster infections (chickenpox or shingles), herpes simplex virus infection, or eczema herpeticum.¹

Systemic administration of tacrolimus in kidney and liver transplant patients associated with increased susceptibility to infection.¹⁴

Phototoxicity

Although phototoxicity not reported in humans, it may be prudent to minimize or avoid natural or artificial sunlight exposure during tacrolimus therapy (including periods when no drug is on skin).¹ Potential effects on skin response to ultraviolet (UV) damage are not known.^a

Animal photocarcinogenicity studies indicate shortened time to skin tumor formation following chronic topical tacrolimus dosing with concurrent UV radiation exposure.¹

Immunocompromised Patients

Safety and efficacy not established and not recommended for use in immunocompromised adults or children.¹² ¹³ ¹⁴ ^a

Renal Effects

Acute renal failure reported rarely in patients receiving topical tacrolimus.^a Increased risk of systemic absorption in patients with epidermal barrier defects, especially following topical application to large body surface areas.^a

Use with caution in patients predisposed to renal impairment.^a

Specific Populations

Pregnancy

Category C.¹

Lactation

Not known whether distributed into milk following topical administration.¹¹ Discontinue nursing or the drug.¹

Blacks

0.03% ointment is ineffective; use the 0.1% ointment.¹ ⁴ ¹¹

Pediatric Use

Safety and efficacy not established and not recommended for use in children <2 years of age.¹ ^a ^c

Use only the 0.03% ointment when topical tacrolimus is indicated in immunocompetent children 2–15 years of age.^a ^c (See Atopic Dermatitis under Uses.)

Long-term effects on the developing immune system in infants and children are not known.¹² ¹³ ¹⁴ ^a

Not recommended for use in immunocompromised children.¹² ¹³ ¹⁴ ^a

Geriatric Use

No substantial differences in safety relative to younger adults.¹

Renal Impairment

Use with caution in patients predisposed to renal impairment.^a (See Renal Effects.)

Common Adverse Effects

Burning sensation, pruritus, flu-like symptoms, skin erythema, headache.¹ ⁵ ⁶

Interactions for Protopic

No formal drug interaction studies have been performed to date.¹

Drugs Affecting Hepatic Microsomal Enzymes

Potential pharmacokinetic interaction with inhibitors of CYP3A4 isoenzyme in patients with widespread and/or erythrodermic disease.¹

Specific Drugs

Drug	Interaction	Comments
Antifungals, azoles	Potential interaction (inhibition of tacrolimus metabolism) in patients with widespread and/or erythrodermic disease (which may increase systemic absorption)¹	Caution advised in patients with widespread and/or erythrodermic disease¹
Calcium-channel blocking agents	Potential interaction (inhibition of tacrolimus metabolism) in patients with widespread and/or erythrodermic disease (which may increase systemic absorption)¹	Caution advised in patients with widespread and/or erythrodermic disease¹
Cimetidine	Potential interaction (inhibition of tacrolimus metabolism) in patients with widespread and/or erythrodermic disease (which may increase systemic absorption)¹	Caution advised in patients with widespread and/or erythrodermic disease¹
Erythromycin	Potential interaction (inhibition of tacrolimus metabolism) in patients with widespread and/or erythrodermic disease (which may increase systemic absorption)¹	Caution advised in patients with widespread and/or erythrodermic disease¹
Meningococcal vaccine	Responses to meningococcal serogroup C similar in children 2–11 years of age with moderate to severe atopic dermatitis treated with topical tacrolimus (0.03%), those treated with topical hydrocortisone, and in healthy children^a
Pneumococcal 23-valent polysaccharide vaccine	Protective antibody titers achieved in limited number of children 2–12 years of age with moderate to severe atopic dermatitis treated with topical tacrolimus (0.03%)^a

Protopic Pharmacokinetics

Absorption

Bioavailability

Minimally absorbed into systemic circulation following topical application to the skin.^a Apparent systemic bioavailability approximately 0.5%.^a

Systemic absorption decreases as atopic dermatititis resolves.^a

Following topical application (53% of total body surface area) in adults, systemic exposure is approximately 30-fold less than following oral administration of immunosuppressive dosages of tacrolimus in adult kidney and liver transplant patients.^a

Blood concentrations in children receiving tacrolimus topically occasionally have been in the concentration range achieved with systemic therapy.¹⁴ ^a

Use of occlusive dressing/wrappings or on the face or neck, large areas of the body (i.e., >50% of the total body surface area), or areas of broken skin may increase systemic exposure to the drug.³ ¹¹

Distribution

Plasma Protein Binding

Approximately 99% (mainly albumin and α₁-acid glycoprotein).^a

Elimination

Metabolism

Studies using systemic tacrolimus indicate that the drug is extensively metabolized in the liver and in the GI tract, principally via oxidation by CYP isoenzymes.¹⁰ ¹¹ ^a

Elimination Route

Following oral or IV administration, eliminated principally in feces (92%); approximately 1–2% excreted unchanged in urine.^a

Half-life

Following IV administration, elimination half-life of approximately 44–48 hours in healthy individuals;^a similar elimination half-life (31–48 hours) following oral administration.^a

Stability

Storage

Topical

Ointment

15–30°C.¹

ActionsActions

Exact mechanism(s) of immunosuppressive action in the treatment of atopic dermatitis not known.¹

Inhibits T-lymphocyte cell activation; shown to inhibit release of mediators from skin mast cells and basophils and to downregulate the expression of high-affinity receptors for immunoglobulin E (IgE) on Langerhans cells.¹ ²

Not genotoxic and does not interact directly with DNA; however, may impair local immunosurveillance.¹⁴

Advice to Patients

Importance of reading the patient information (medication guide) provided by the manufacturer before initiating therapy and each time the prescription is refilled.^a ^b

Importance of informing clinicians of other medical conditions, including Netherton’s syndrome, skin infections (e.g., chicken pox, herpes), or weakened immune system.^a ^b

Advise patients that tacrolimus is for external use on affected areas of the skin only.^a ^b Importance of patients or caregivers washing their hands before and after application if hands are not an area for treatment.¹

Advise patients not to bathe, shower, or swim immediately after application.^b

Importance of avoiding contact with the eyes.^a ^b

Importance of following the clinician’s advice regarding use of other topical preparations; importance of maintaining good skin care practices; apply moisturizers (if used) after tacrolimus.^a ^b

Advise patients to discontinue tacrolimus when the signs and symptoms (e.g., itching, rash, redness) of atopic dermatitis (eczema) resolve, or as directed by clinician.^a ^b Importance of following the clinician’s advice if symptoms recur after a course of treatment.^a ^b

Importance of not using the drug in children <2 years of age.^a

Importance of using only the 0.03% ointment in children 2–15 years of age;^a ^b either 0.03% or 0.1% ointment may be used in adults and adolescents ≥16 years of age.^a ^b

Importance of avoiding use of bandages, dressings, or wrappings on treated skin.^a ^b

Importance of not using the drug for any disorder other than that for which it was prescribed.¹

Importance of using tacrolimus exactly as prescribed and of not using the drug continuously for a long period of time.^a ^b Importance of using the minimum amount required to control signs and symptoms of atopic dermatitis; importance of using the drug for short-term or intermittent therapy (e.g., courses repeated after treatment-free intervals) only.¹² ¹³ ^a ^b

Importance of reporting persistently swollen glands or any other adverse reactions to clinician.^a ^b

Importance of notifying clinician if the signs and symptoms of atopic dermatitis do not improve after 6 weeks of therapy or at any time become noticeably worse.^a ^b

Importance of notifying clinician if a skin infection develops during treatment with tacrolimus.^a ^b

Importance of avoiding or limiting exposure of unprotected skin to natural or artificial sunlight (tanning beds or UVA/B light) while using tacrolimus ointment (even when the drug is not on the skin); wear protective clothing and use a broad-spectrum sunscreen with a high protection factor.³ ¹¹ ^a ^b

Importance of not swallowing tacrolimus; contact clinician if swallowed.^a ^b

Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription or OTC drugs, dietary supplements, herbal supplements, any other skin product, or any form of phototherapy (UVA or UVB).⁹ ^a ^b

Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹

Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Tacrolimus
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Topical	Ointment	0.03%	Protopic	Astellas
		0.1%	Protopic	Astellas

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 04/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Protopic 0.03% Ointment (ASTELLAS): 60/$251.17 or 180/$732.8

Protopic 0.03% Ointment (ASTELLAS): 30/$132.99 or 90/$384.15

Protopic 0.1% Ointment (ASTELLAS): 60/$243.24 or 180/$691.04

Protopic 0.1% Ointment (ASTELLAS): 100/$403.88 or 300/$1168.43

Protopic 0.1% Ointment (ASTELLAS): 30/$124.42 or 90/$359.4

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions July 01, 2006. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Astellas Pharma US, Inc. Protopic (tacrolimus) ointment prescribing information. Deerfield, IL; 2005 Jul.

2. Bekersky I, Fitzsimmons W, Tanase A et al. Nonclinical and early clinical development of tacrolimus ointment for the treatment of atopic dermatitis. J Am Acad Dermatol. 2001; 44(1 Suppl):S17-27. [IDIS 457747] [PubMed 11145792]

3. Dermatologic and Ophthalmic Drugs Advisory Committee Meeting. 54th meeting. Bethesda, MD: Food and Drug Administration; 2000 Nov 16.

4. Hanifin JM, Ling MR, Langley R et al. Tacrolimus ointment for the treatment of atopic dermatitis in adult patients: part I, efficacy. J Am Acad Dermatol. 2001; 44(1 Suppl):S28-38.

5. Soter NA, Fleischer AB Jr, Webster GF et al. Tacrolimus ointment for the treatment of atopic dermatitis in adult patients: part II, safety. J Am Acad Dermatol. 2001; 44(1 Suppl):S39-46.

6. Paller A, Eichenfield LF, Leung DY et al. A 12-week study of tacrolimus ointment for the treatment of atopic dermatitis in pediatric patients. J Am Acad Dermatol. 2001; 44(1 Suppl):S47-57.

7. Kang S, Lucky AW, Pariser D et al. Long-term safety and efficacy of tacrolimus ointment for the treatment of atopic dermatitis in children. J Am Acad Dermatol. 2001; 44(1 Suppl):S58-64. [IDIS 457751] [PubMed 11145796]

8. Reitamo S, Wollenberg A, Schopf E et al for the European Tacrolimus Ointment Study Group. Safety and efficacy of 1 year of tacrolimus ointment monotherapy in adults with atopic dermatitis. Arch Dermatol. 2000; 136:999-1006. [IDIS 451208] [PubMed 10926735]

9. Astellas Pharma US, Inc. Protopic (tacrolimus) ointment patient information. Deerfield, IL; 2005 Apr.

10. Fujisawa Healthcare, Inc. Prograf (tacrolimus) for injection and oral capsules prescribing information. Deerfield, IL; 1998 Oct.

11. Reviewers’ comments (personal observations).

12. Anon. FDA issues public health advisory informing health care providers of safety concerns associated with the use of two eczema drugs, Elidel and Protopic. FDA Talk Paper. Rockville, MD: Food and Drug Administration; 2005 March 10. From the FDA website: . Accessed on May 25, 2005.

13. Food and Drug Administration (FDA). FDA Public Health Advisory regarding potential cancer risk from use of Elidel (pimecrolimus) cream and Protopic (tacrolimus) ointment. From FDA website: . 2005 Mar 10. Accessed on May 25, 2005.

14. Food and Drug Administration (FDA). FDA alert for healthcare professionals regarding potential cancer risk from use of tacrolimus (marketed as Protopic). From FDA website: . Accessed on May 25, 2005.

a. Astellas Pharma US, Inc. Protopic (tacrolimus) ointment 0.03 and 0.1% prescribing information. Deerfield, IL; 2006 Jan.

b. Astellas Pharma US, Inc. Protopic (tacrolimus) ointment 0.03 and 0.1% medication guide. Deerfield, IL; 2006 Jan.

c. Rico MJ. Dear health care provider letter regarding important safety information regarding Protopic and rare cases of malignancy reported in patients treated with topical calcineurin inhibitors. Deerfield, IL; 2006 Jan 19.

Compare Protopic topical with other medications

Atopic Dermatitis
Perioral Dermatitis

Provenge

Generic Name: sipuleucel-t (Intravenous route)

si-pu-LOO-sel - tee

Commonly used brand name(s)

In the U.S.

Provenge

Available Dosage Forms:

Suspension

Uses For Provenge

Sipuleucel-T is used to treat certain types of advanced prostate cancer. This medicine is made from your own immune cells (autologous cellular immunotherapy).

This medicine is available only with your doctor's prescription.

Before Using Provenge

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

No information is available on the relationship of age to the effects of sipuleucel-T in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of sipuleucel-T in the elderly.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of Provenge

A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed in one of your veins.

Your doctor will tell you to have your immune cells collected three days before each scheduled infusion of this medicine at a cell collection center. This collection process is called leukapheresis. Your collected blood cells are mixed with a protein to make them ready for your infusion.

The medicine is usually given as 3 doses, spaced 2 weeks apart. This medicine must be given slowly, so the needle will remain in place for one hour. You may also receive acetaminophen (e.g., Tylenol®) and diphenhydramine (e.g., Benadryl®) to help prevent possible infusion reactions.

It is very important that you receive all doses of this medicine. Try to keep all scheduled appointments. If you miss a dose, your medicine will not be usable. Your doctor will work with you to schedule a new appointment at the cell collection center. You may also get a new appointment for your infusion.

Precautions While Using Provenge

It is very important that your doctor check your progress at regular visits. Your doctor will do blood tests to make sure that sipuleucel-T is working properly and to check for unwanted effects.

This medicine may cause fever; chills; dizziness; fast heartbeat; joint pain; nausea and vomiting; shortness of breath; troubled breathing; or unusual tiredness or weakness within a few hours after you receive it. Check with your doctor or nurse right away if you have any of these symptoms.

Call your doctor right away if you start to have a cough, weight loss, fever, or redness or pain at the infusion or collection sites. These may be signs that you have an infection.

Check with your doctor right away if you have chest pain or discomfort, dizziness, fainting, pounding or rapid pulse, or fast, slow, or uneven heartbeat. These maybe symptoms of a heart rhythm problem.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Provenge Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Bladder pain

bloating or swelling of the face, arms, hands, lower legs, or feet

bloody or cloudy urine

body aches or pain

chest pain

chills

confusion

cough

diarrhea

difficult, burning, or painful urination

difficulty with breathing

difficulty with speaking

double vision

ear congestion

fever

frequent urge to urinate

general feeling of discomfort or illness

headache

inability to move the arms, legs, or facial muscles

inability to speak

joint pain

loss of appetite

loss of voice

lower back or side pain

muscle aches and pains

nasal congestion

nausea

pale skin

rapid weight gain

runny nose

shivering

shortness of breath

slow speech

sneezing

sore throat

sweating

tightness in the chest

tingling of the hands or feet

trouble sleeping

troubled breathing with exertion

unusual bleeding or bruising

unusual tiredness or weakness

unusual weight gain or loss

vomiting

wheezing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Back pain

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

decreased weight

dizziness

feeling of warmth

lack or loss of strength

loss of appetite

muscle ache

muscle or bone pain

muscle spasms

neck pain

rash

redness of the face, neck, arms, and occasionally, upper chest

sleeplessness

sudden sweating

unable to sleep

weight loss

Less common

Shakiness in the legs, arms, hands, or feet

trembling or shaking of the hands or feet

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Provenge side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Provenge resources

Provenge Side Effects (in more detail)
Provenge Use in Pregnancy & Breastfeeding
Provenge Drug Interactions
Provenge Support Group
2 Reviews for Provenge - Add your own review/rating

Provenge Prescribing Information (FDA)

Provenge MedFacts Consumer Leaflet (Wolters Kluwer)

Provenge Consumer Overview

Sipuleucel-T Professional Patient Advice (Wolters Kluwer)

Compare Provenge with other medications

Prostate Cancer

Pseudoephedrine Sustained-Release Capsules

Pronunciation: soo-doe-e-FED-rin
Generic Name: Pseudoephedrine
Brand Name: Sudafed 12 Hour

Pseudoephedrine Sustained-Release Capsules are used for:

Relieving congestion due to colds, flu, hay fever, and other allergies. It may also be used for other conditions as determined by your doctor.

Pseudoephedrine Sustained-Release Capsules are a decongestant. It works by reducing swelling and constricting blood vessels in the nasal passages, allowing you to breathe more easily.

Do NOT use Pseudoephedrine Sustained-Release Capsules if:

you are allergic to any ingredient in Pseudoephedrine Sustained-Release Capsules

you are taking furazolidone or have taken a monoamine oxidase (MAO) inhibitor (eg, phenelzine) in the last 14 days

you have severe high blood pressure, severe heart blood vessel disease, a rapid heartbeat, or severe heart problems

Contact your doctor or health care provider right away if any of these apply to you.

Before using Pseudoephedrine Sustained-Release Capsules:

Some medical conditions may interact with Pseudoephedrine Sustained-Release Capsules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have a history of heart problems, diabetes, glaucoma, an enlarged prostate or other prostate problems, adrenal gland problems, high blood pressure, seizures, stroke, blood vessel problems, or an overactive thyroid

Some MEDICINES MAY INTERACT with Pseudoephedrine Sustained-Release Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:

Rauwolfia derivatives (eg, reserpine) because the effectiveness of Pseudoephedrine Sustained-Release Capsules may be decreased

Beta-blockers (eg, propranolol), cocaine, furazolidone, indomethacin, methyldopa, MAO inhibitors (eg, phenelzine), oxytocic medicines (eg, oxytocin), rauwolfia derivatives (eg, reserpine), or tricyclic antidepressants (eg, amitriptyline) because the actions and side effects of Pseudoephedrine Sustained-Release Capsules may be increased

Bromocriptine, catechol-O-methyltransferase (COMT) inhibitors (eg, entacapone), digoxin, or droxidopa because the actions and side effects of these medicines may be increased

Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because its effectiveness may be decreased by Pseudoephedrine Sustained-Release Capsules

This may not be a complete list of all interactions that may occur. Ask your health care provider if Pseudoephedrine Sustained-Release Capsules may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Pseudoephedrine Sustained-Release Capsules:

Use Pseudoephedrine Sustained-Release Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Pseudoephedrine Sustained-Release Capsules with food, water, or milk to minimize stomach irritation.

Swallow Pseudoephedrine Sustained-Release Capsules whole. Do not break, crush, or chew before swallowing.

If you miss a dose of Pseudoephedrine Sustained-Release Capsules and are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Pseudoephedrine Sustained-Release Capsules.

Important safety information:

Pseudoephedrine Sustained-Release Capsules may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Pseudoephedrine Sustained-Release Capsules. Using Pseudoephedrine Sustained-Release Capsules alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.

If your symptoms do not improve within 7 days or if you develop a high fever, check with your doctor.

If you have trouble sleeping, ask your pharmacist or doctor about the best time to take Pseudoephedrine Sustained-Release Capsules.

Do not take diet or appetite control medicines while you are taking Pseudoephedrine Sustained-Release Capsules.

Pseudoephedrine Sustained-Release Capsules contains pseudoephedrine. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains pseudoephedrine. If it does or if you are uncertain, contact your doctor or pharmacist.

Diabetes patients - Pseudoephedrine Sustained-Release Capsules may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine.

Use Pseudoephedrine Sustained-Release Capsules with caution in the ELDERLY because they may be more sensitive to its effects.

Use Pseudoephedrine Sustained-Release Capsules with extreme caution in CHILDREN younger than 12 years of age. Safety and effectiveness in this age group have not been confirmed.

PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Pseudoephedrine Sustained-Release Capsules during pregnancy. It is unknown if Pseudoephedrine Sustained-Release Capsules are excreted in breast milk. If you are or will be breast-feeding while you are using Pseudoephedrine Sustained-Release Capsules, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Pseudoephedrine Sustained-Release Capsules:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Difficulty urinating; dizziness; headache; nausea; nervousness; restlessness; sleeplessness; stomach irritation.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Pseudoephedrine side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include confusion; hallucinations; irregular or unusually slow or rapid heartbeat; rapid breathing; seizures.

Proper storage of Pseudoephedrine Sustained-Release Capsules:

Store Pseudoephedrine Sustained-Release Capsules at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Pseudoephedrine Sustained-Release Capsules out of the reach of children and away from pets.

General information:

If you have any questions about Pseudoephedrine Sustained-Release Capsules, please talk with your doctor, pharmacist, or other health care provider.

Pseudoephedrine Sustained-Release Capsules are to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Pseudoephedrine Sustained-Release Capsules. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Pseudoephedrine resources

Pseudoephedrine Side Effects (in more detail)
Pseudoephedrine Use in Pregnancy & Breastfeeding
Drug Images
Pseudoephedrine Drug Interactions
Pseudoephedrine Support Group
8 Reviews for Pseudoephedrine - Add your own review/rating

Compare Pseudoephedrine with other medications

Nasal Congestion

Pseudovent

Generic Name: guaifenesin and pseudoephedrine (gwye FEN e sin, soo doe e FED rin)

Brand Names: Altarussin PE, Ambifed, Biotuss PE, D-Feda II, Despec-SR, Dynex, ExeFen, Guiatex II SR, Maxifed, Maxifed-G, Medent LD, Medent-LDI, Mucinex D, Nasabid SR, Nasatab LA, Nomuc-PE, Poly-Vent IR, Poly-Vent, Jr., Pseudatex, Pseudo GG, Pseudo GG TR, Pseudo Max, Q-Tussin PE, Respaire-120 SR, Robitussin Severe Congestion, Ru-Tuss Jr., Sudafed Non Drying Sinus, SudaTex-G, Touro LA-LD, Triaminic Softchews Chest Congestion, We Mist II LA, We Mist LA

What is guaifenesin and pseudoephedrine?

Guaifenesin is an expectorant. It helps loosen congestion in your chest and throat, making it easier to cough out through your mouth.

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of guaifenesin and pseudoephedrine is used to treat nasal and sinus congestion, and to reduce chest congestion caused by the common cold, infections, or allergies.

Guaifenesin and pseudoephedrine may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about guaifenesin and pseudoephedrine?

Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body. Do not use any other over-the-counter cough or cold medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains a decongestant or expectorant.

What should I discuss with my healthcare provider before taking guaifenesin and pseudoephedrine?

Do not use this medication if you are allergic to guaifenesin or pseudoephedrine, or to other decongestants, diet pills, stimulants, or ADHD medications. Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body.

Before taking guaifenesin and pseudoephedrine, tell your doctor if you are allergic to any drugs, or if you have:

heart disease or high blood pressure;

diabetes; or

a thyroid disorder.

If you have any of these conditions, you may not be able to use this medication, or you may need a dosage adjustment or special tests during treatment.

This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. This medication may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Artificially-sweetened liquid forms of cold medicine may contain phenylalanine. This would be important to know if you have phenylketonuria (PKU). Check the ingredients and warnings on the medication label if you are concerned about phenylalanine.

How should I take guaifenesin and pseudoephedrine?

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts, or use it for longer than recommended. Cold medicine is usually taken only for a short time until your symptoms clear up.

Always ask a doctor before giving cough or cold medicine to a child. Death can occur from the misuse of cough or cold medicine in very young children. Do not crush, chew, break, or open a controlled-release, delayed-release, or extended-release tablet or capsule. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking or opening the pill would cause too much of the drug to be released at one time.

Measure the liquid form of this medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Drink extra fluids to help loosen the congestion and lubricate your throat while you are taking this medication. Take guaifenesin and pseudoephedrine with food if it upsets your stomach. Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.

Store this medicine at room temperature, away from heat, light, and moisture.

What happens if I miss a dose?

Since cough or cold medicine is usually taken only as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include nausea, vomiting, dizziness, and feeling restless or nervous.

What should I avoid while taking guaifenesin and pseudoephedrine?

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol while you are taking this medicine.

Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice. Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.

Do not use any other over-the-counter cold, allergy, or cough medicine without first asking your doctor or pharmacist. Guaifenesin and pseudoephedrine are contained in many medicines available over the counter. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you are using to see if it contains guaifenesin or pseudoephedrine.

Guaifenesin and pseudoephedrine side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking this medication and call your doctor at once if you have any of these serious side effects:

fast, pounding, or uneven heartbeat;

severe dizziness, anxiety, restless feeling, or nervousness;

easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or

increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure).

Keep taking guaifenesin and pseudoephedrine and talk to your doctor if you have any of these less serious side effects:

dizziness or headache;

feeling excited or restless;

sleep problems (insomnia);

nausea, vomiting, or stomach upset;

mild loss of appetite;

warmth, tingling, or redness under your skin; or

skin rash or itching.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect guaifenesin and pseudoephedrine?

Before taking guaifenesin and pseudoephedrine, tell your doctor if you are using any of the following drugs:

methyldopa (Aldomet);

medicines to treat high blood pressure;

a beta-blocker such as atenolol (Tenormin), carteolol (Cartrol), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal), sotalol (Betapace), timolol (Blocadren), and others; or

antidepressants such as amitriptyline (Elavil), clomipramine (Anafranil), imipramine (Janimine, Tofranil), and others.

This is not a complete list and there may be other drugs that can affect guaifenesin and pseudoephedrine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More Pseudovent resources

Pseudovent Side Effects (in more detail)
Pseudovent Use in Pregnancy & Breastfeeding
Drug Images
Pseudovent Drug Interactions
Pseudovent Support Group
5 Reviews for Pseudovent - Add your own review/rating

Pseudovent Consumer Overview

Congestac MedFacts Consumer Leaflet (Wolters Kluwer)

Entex PSE Controlled-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)

Mucinex D Consumer Overview

Mucinex D Prescribing Information (FDA)

Robitussin Severe Congestion MedFacts Consumer Leaflet (Wolters Kluwer)

Zephrex LA Sustained-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Pseudovent with other medications

Cough and Nasal Congestion

Where can I get more information?

Your pharmacist can provide more information about guaifenesin and pseudoephedrine.

See also: Pseudovent side effects (in more detail)

Pseudovent Ped

What is Pseudovent Ped (guaifenesin and pseudoephedrine)?

Guaifenesin is an expectorant. It helps loosen congestion in your chest and throat, making it easier to cough out through your mouth.

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of guaifenesin and pseudoephedrine is used to treat nasal and sinus congestion, and to reduce chest congestion caused by the common cold, infections, or allergies.

Guaifenesin and pseudoephedrine may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Pseudovent Ped (guaifenesin and pseudoephedrine)?

What should I discuss with my healthcare provider before taking Pseudovent Ped (guaifenesin and pseudoephedrine)?

Before taking guaifenesin and pseudoephedrine, tell your doctor if you are allergic to any drugs, or if you have:

heart disease or high blood pressure;

diabetes; or

a thyroid disorder.

If you have any of these conditions, you may not be able to use this medication, or you may need a dosage adjustment or special tests during treatment.

How should I take Pseudovent Ped (guaifenesin and pseudoephedrine)?

Measure the liquid form of this medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.

Store this medicine at room temperature, away from heat, light, and moisture.

What happens if I miss a dose?

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include nausea, vomiting, dizziness, and feeling restless or nervous.

What should I avoid while taking Pseudovent Ped (guaifenesin and pseudoephedrine)?

Pseudovent Ped (guaifenesin and pseudoephedrine) side effects

fast, pounding, or uneven heartbeat;

severe dizziness, anxiety, restless feeling, or nervousness;

easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or

increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure).

Keep taking guaifenesin and pseudoephedrine and talk to your doctor if you have any of these less serious side effects:

dizziness or headache;

feeling excited or restless;

sleep problems (insomnia);

nausea, vomiting, or stomach upset;

mild loss of appetite;

warmth, tingling, or redness under your skin; or

skin rash or itching.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Pseudovent Ped (guaifenesin and pseudoephedrine)?

Before taking guaifenesin and pseudoephedrine, tell your doctor if you are using any of the following drugs:

methyldopa (Aldomet);

medicines to treat high blood pressure;

a beta-blocker such as atenolol (Tenormin), carteolol (Cartrol), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal), sotalol (Betapace), timolol (Blocadren), and others; or

antidepressants such as amitriptyline (Elavil), clomipramine (Anafranil), imipramine (Janimine, Tofranil), and others.

More Pseudovent Ped resources

Pseudovent Ped Side Effects (in more detail)
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Cough and Nasal Congestion

Where can I get more information?

Your pharmacist can provide more information about guaifenesin and pseudoephedrine.

See also: Pseudovent Ped side effects (in more detail)