Allergy Relief D12

Drug overview for ALLERGY RELIEF D12 (loratadine/pseudoephedrine sulfate):

Generic name: LORATADINE/PSEUDOEPHEDRINE SULFATE (lor-AT-a-deen/SOO-doe-e-FED-rin)
Drug class: Amphetamines/Anorexiants/Stimulants
Therapeutic class: Respiratory Therapy Agents

Loratadine, a derivative of azatadine , is a second generation Pseudoephedrine is a sympathomimetic agent that occurs naturally in plants antihistamine. of the genus Ephedra; the drug acts directly on both alpha- and, to a lesser degree, beta-adrenergic receptors.

Loratadine shares the uses of other antihistamines, including the Pseudoephedrine is used as a nasal decongestant for self-medication for the management of allergic rhinitis and chronic idiopathic urticaria. For temporary relief of nasal congestion associated with upper respiratory additional information on these and other uses of antihistamines,see Uses allergy and to provide temporary relief of sinus congestion and pressure. in the Antihistamines General Statement 4:00.

The drug also has been used for self-medication in the symptomatic prevention of otitic barotrauma+ (aerotitis ( barotitis) media). Pseudoephedrine also has been misused for clandestine synthesis of methamphetamine and methcathinone for illicit use.

DRUG IMAGES

ALLERGY-CONGESTION RLF 12H TAB

The following indications for ALLERGY RELIEF D12 (loratadine/pseudoephedrine sulfate) have been approved by the FDA:

Indications:
Allergic conjunctivitis
Allergic rhinitis
Cold symptoms
Nasal congestion
Perennial allergic rhinitis
Rhinorrhea
Seasonal allergic rhinitis
Sneezing
Vasomotor rhinitis

Professional Synonyms:
Allergy eye itch
Atopic conjunctivitis
Atopic rhinitis
Intermittent allergic rhinitis
Itchy eyes due to allergies
Nasal stuffiness
Non-seasonal allergic rhinitis
Ocular itching due to allergies
Periodic runny nose
Seasonal allergy

The following dosing information is available for ALLERGY RELIEF D12 (loratadine/pseudoephedrine sulfate):

Dosing
Administration
ALLERGY RELIEF D-12
Generic

In patients with chronic renal impairment (creatinine clearance of 30 mL/minute or less), both oral bioavailability and peak plasma concentrations of loratadine and desloratadine may be increased compared with individuals with normal renal function. However, elimination half-lives of the drug and its active metabolite appear to be similar to those of individuals with normal renal function. Patients with renal impairment receiving loratadine for self-medication should be advised to consult a clinician before initiating therapy, since a different dosage may be recommended.

Therapy with loratadine conventional or orally disintegrating tablets or oral solution should be initiated at a dosage of 10 mg every other day in adults and children 6 years of age and older with a glomerular filtration rate less than 30 mL/minute and at a dosage of 5 mg every other day in children 2-5 years of age with renal insufficiency. In addition, therapy with the commercially available tablets containing loratadine in fixed combination with pseudoephedrine sulfate should be initiated in adults and children 12 years of age and older with a glomerular filtration rate less than 30 mL/minute at a dosage of 5 mg once daily when the 12-hour formulation is used or at a dosage of 10 mg every other day when the 24-hour formulation is used, since clearance of both loratadine and pseudoephedrine are decreased in such patients. Hemodialysis does not appear to affect the pharmacokinetics of loratadine or desloratadine.

The pharmacokinetics of loratadine and its active metabolite also may be altered in patients with hepatic impairment and dosage adjustment may be necessary. Therefore, patients with hepatic impairment receiving loratadine for self-medication should be advised to consult a clinician before initiating therapy, since a different dosage may be recommended. Therapy with loratadine conventional or orally disintegrating tablets or oral solution should be initiated at a dosage of 10 mg every other day in adults and children 6 years of age and older with hepatic failure and at a dosage of 5 mg every other day in children 2-5 years of age with hepatic failure. Since fixed-ratio combination preparations do not permit individual titration of dosages, and clearance of loratadine is decreased more substantially than that of pseudoephedrine sulfate in patients with hepatic impairment, the manufacturer recommends that tablets containing loratadine in fixed combination with pseudoephedrine sulfate generally not be used in such patients.

Loratadine is administered orally. Loratadine conventional tablets, orally disintegrating tablets, and the commercially available tablets containing the drug in fixed combination with pseudoephedrine sulfate can be administered without regard to meals. Although the oral bioavailability of loratadine is increased when the drug is administered as the orally disintegrating tablet without water, the bioavailability of the active metabolite desloratadine (descarboethoxyloratadine) is unaffected, and the manufacturers state that the orally disintegrating tablets can be administered with or without water.

The orally disintegrating tablets are administered by placing a tablet on the tongue, where it disintegrates within a few seconds, and then subsequently swallowing with or without water. Tablets containing loratadine in fixed combination with pseudoephedrine sulfate should be swallowed intact and patients should be instructed not to break, chew, or dissolve such tablets. Patients also should be instructed to take Claritin-D(R) 24 Hour extended-release tablets with a full glass of water.

Pseudoephedrine hydrochloride and sulfate are administered orally. Pseudoephedrine hydrochloride 240-mg extended-release tablets should be administered orally once daily and swallowed whole with water; the extended-release tablets should not be divided, crushed, chewed, or dissolved. Patients should be advised that the tablet does not completely dissolve and may be passed in the stool.

Dosing information for ALLERGY RELIEF D-12
DRUG LABEL	DOSING TYPE	DOSING INSTRUCTIONS
ALLERGY RELIEF D-12 TABLET	Maintenance	Adults take 1 tablet by oral route every 12 hours

No generic dosing information available.

The following drug interaction information is available for ALLERGY RELIEF D12 (loratadine/pseudoephedrine sulfate):

Contraindicated
Severe
Moderate

There are 1 contraindications. These drug combinations generally should not be dispensed or administered to the same patient. A manufacturer label warning that indicates the contraindication warrants inclusion of a drug combination in this category, regardless of clinical evidence or lack of clinical evidence to support the contraindication.

Drug Interaction	Drug Names
Sympathomimetics (Indirect & Mixed Acting)/MAOIs SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient. MECHANISM OF ACTION: Catecholamine stores increased by MAOIs can be released by indirect acting sympathomimetics such as ephedrine and amphetamine. MAO inhibitors also interfere with gut and liver metabolism of direct acting sympathomimetics (e.g oral phenylephrine). CLINICAL EFFECTS: Concurrent use of MAOIs may result in potentiation of sympathomimetic effects, which may result in headaches, hypertensive crisis, toxic neurological effects, and malignant hyperpyrexia. Fatalities have occurred. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Concurrent use of monoamine oxidase inhibitors and sympathomimetics is contraindicated. The manufacturers of sympathomimetic agents recommend waiting 14 days after discontinuation of MAO inhibitors before initiating the sympathomimetic. DISCUSSION: Indirect acting sympathomimetic amines may cause abrupt elevation of blood pressure when administered to patients taking monoamine oxidase inhibitors, resulting in a potentially fatal hypertensive crisis. Mixed (direct and indirect) acting sympathomimetics have also been shown to interact with monoamine oxidase inhibitors depending on their degree of indirect action. The direct-acting sympathomimetics have not been reported to interact. Dopamine is metabolized by monoamine oxidase, and its pressor effect is enhanced by monoamine oxidase inhibitors. Since procarbazine, an antineoplastic agent, is a weak monoamine oxidase inhibitor, hypertensive reactions may result from its concurrent use with indirect and mixed acting sympathomimetics. Furazolidone, an antibacterial with monoamine oxidase inhibitor action, has also been shown to interact with indirect acting sympathomimetics. Linezolid is another antibacterial with monoamine oxidase inhibitor properties. Metaxalone is a weak inhibitor of MAO. Foods containing large amounts of tyramine have also been implicated in this interaction. Methylene blue, when administered intravenously, has been shown to reach sufficient concentrations to be a potent inhibitor of MAO-A. At recommended dosages, rasagiline, oral selegiline, and transdermal selegiline up to 6mg/day are selective for MAO-B; however, at higher dosages they have been shown to lose their selectivity. One or more of the drug pairs linked to this monograph have been included in a list of interactions that should be considered "high-priority" for inclusion and should not be inactivated in EHR systems. This DDI subset was vetted by an expert panel commissioned by the U.S. Office of the National Coordinator (ONC) for Health Information Technology.	EMSAM, FURAZOLIDONE, MARPLAN, MATULANE, METAXALONE, METHYLENE BLUE, NARDIL, PARNATE, PHENELZINE SULFATE, PROCARBAZINE HCL, PROVAYBLUE, SELEGILINE HCL, TRANYLCYPROMINE SULFATE

Drug Interaction

Drug Names

Sympathomimetics (Indirect & Mixed Acting)/MAOIs

SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

MECHANISM OF ACTION: Catecholamine stores increased by MAOIs can be released by indirect acting sympathomimetics such as ephedrine and amphetamine. MAO inhibitors also interfere with gut and liver metabolism of direct acting sympathomimetics (e.g oral phenylephrine).

CLINICAL EFFECTS: Concurrent use of MAOIs may result in potentiation of sympathomimetic effects, which may result in headaches, hypertensive crisis, toxic neurological effects, and malignant hyperpyrexia. Fatalities have occurred.

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: Concurrent use of monoamine oxidase inhibitors and sympathomimetics is contraindicated. The manufacturers of sympathomimetic agents recommend waiting 14 days after discontinuation of MAO inhibitors before initiating the sympathomimetic.

DISCUSSION: Indirect acting sympathomimetic amines may cause abrupt elevation of blood pressure when administered to patients taking monoamine oxidase inhibitors, resulting in a potentially fatal hypertensive crisis. Mixed (direct and indirect) acting sympathomimetics have also been shown to interact with monoamine oxidase inhibitors depending on their degree of indirect action. The direct-acting sympathomimetics have not been reported to interact.

Dopamine is metabolized by monoamine oxidase, and its pressor effect is enhanced by monoamine oxidase inhibitors. Since procarbazine, an antineoplastic agent, is a weak monoamine oxidase inhibitor, hypertensive reactions may result from its concurrent use with indirect and mixed acting sympathomimetics. Furazolidone, an antibacterial with monoamine oxidase inhibitor action, has also been shown to interact with indirect acting sympathomimetics.

Linezolid is another antibacterial with monoamine oxidase inhibitor properties. Metaxalone is a weak inhibitor of MAO. Foods containing large amounts of tyramine have also been implicated in this interaction.

Methylene blue, when administered intravenously, has been shown to reach sufficient concentrations to be a potent inhibitor of MAO-A. At recommended dosages, rasagiline, oral selegiline, and transdermal selegiline up to 6mg/day are selective for MAO-B; however, at higher dosages they have been shown to lose their selectivity. One or more of the drug pairs linked to this monograph have been included in a list of interactions that should be considered "high-priority" for inclusion and should not be inactivated in EHR systems.

This DDI subset was vetted by an expert panel commissioned by the U.S. Office of the National Coordinator (ONC) for Health Information Technology.

EMSAM, FURAZOLIDONE, MARPLAN, MATULANE, METAXALONE, METHYLENE BLUE, NARDIL, PARNATE, PHENELZINE SULFATE, PROCARBAZINE HCL, PROVAYBLUE, SELEGILINE HCL, TRANYLCYPROMINE SULFATE

There are 5 severe interactions. These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.

Drug Interaction	Drug Names
Ergot Alkaloids/Sympathomimetics SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Concurrent use of ergot alkaloids and sympathomimetics may result in additive or synergistic effect on peripheral blood vessels. CLINICAL EFFECTS: Concurrent use of ergot alkaloids and sympathomimetics may result in increased blood pressure due to peripheral vasoconstriction. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: When possible, avoid the concurrent use of ergot alkaloids and sympathomimetics. If concurrent use is warranted, monitor blood pressure and for signs of vasoconstriction. Decreasing the dose of one or both drugs may be necessary. DISCUSSION: There have been reports of severe vasoconstriction resulting in gangrene in patients receiving intravenous ergonovine with dopamine or norepinephrine.	DIHYDROERGOTAMINE MESYLATE, ERGOLOID MESYLATES, ERGOMAR, ERGOTAMINE TARTRATE, ERGOTAMINE-CAFFEINE, METHYLERGONOVINE MALEATE, METHYSERGIDE MALEATE, MIGERGOT, MIGRANAL, TRUDHESA
Mixed;Indirect Sympathomimetics/Selected MAOIs SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Catecholamine stores increased by MAOIs can be released by indirect acting sympathomimetics such as ephedrine and amphetamine. MAO inhibitors also interfere with gut and liver metabolism of direct acting sympathomimetics (e.g oral phenylephrine). CLINICAL EFFECTS: Concurrent use of MAOIs may result in potentiation of sympathomimetic effects, which may result in headaches, hypertensive crisis, toxic neurological effects, and malignant hyperpyrexia. Fatalities have occurred with combinations of sympathomimetics and MAO-A inhibitors. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Concurrent use of MAO-A inhibitors and sympathomimetics is contraindicated. The manufacturers of sympathomimetic agents recommend waiting 14 days after discontinuation of MAO inhibitors before initiating the sympathomimetic. Patients receiving direct or indirect acting sympathomimetics should not receive linezolid unless they are monitored for potential increases in blood pressure. Initial dosages of dopamine and epinephrine should be reduced. At recommended dosages, oral selegiline and transdermal selegiline up to 6mg/day are selective for MAO-B; however, at higher dosages they have been shown to lose their selectivity. Patients receiving higher dosages of selegiline should be considered susceptive to this interaction. DISCUSSION: Indirect acting sympathomimetic amines may cause abrupt elevation of blood pressure when administered to patients taking monoamine oxidase inhibitors, resulting in a potentially fatal hypertensive crisis. Mixed (direct and indirect) acting sympathomimetics have also been shown to interact with monoamine oxidase inhibitors depending on their degree of indirect action. The direct-acting sympathomimetics have not been reported to interact. Dopamine is metabolized by monoamine oxidase, and its pressor effect is enhanced by monoamine oxidase inhibitors. Furazolidone, an antibacterial with monoamine oxidase inhibitor action, has also been shown to interact with indirect acting sympathomimetics. Foods containing large amounts of tyramine have also been implicated in this interaction. A significant pressor response was observed in normal subjects receiving linezolid and tyramine doses of more than 100 mg. Administration of linezolid (600 mg BID for 3 days) with pseudoephedrine (60 mg q 4 hours for 2 doses) increased blood pressure by 32 mmHg. Administration of linezolid (600 mg BID for 3 days) with phenylpropanolamine (25 mg q 4 hours for 2 doses) increased blood pressure by 38 mmHg. One or more of the drug pairs linked to this monograph have been included in a list of interactions that should be considered "high-priority" for inclusion and should not be inactivated in EHR systems. This DDI subset was vetted by an expert panel commissioned by the U.S. Office of the National Coordinator (ONC) for Health Information Technology.	EMSAM, LINEZOLID, LINEZOLID-0.9% NACL, LINEZOLID-D5W, SELEGILINE HCL, XADAGO, ZELAPAR, ZYVOX
Radioactive Iodide/Agents that Affect Iodide SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Many compounds can affect iodide protein binding and alter iodide pharmacokinetics and pharmacodynamics.(1,2) CLINICAL EFFECTS: Compounds that affect iodide pharmacokinetics and pharmacodynamics may impact the effectiveness of radioactive iodide.(1,2 PREDISPOSING FACTORS: Compounds that affect iodide pharmacokinetics and pharmacodynamics are expected to have the most impact during therapy using radioactive iodide. Diagnostic procedures would be expected to be impacted less. PATIENT MANAGEMENT: Discuss the use of agents that affect iodide pharmacokinetics and pharmacodynamics with the patient's oncologist.(1,2) DISCUSSION: Many agents interact with radioactive iodine. The average duration of effect is: anticoagulants - 1 week antihistamines - 1 week anti-thyroid drugs, e.g: carbimazole, methimazole, propylthiouracil - 3-5 days corticosteroids - 1 week iodide-containing medications, e.g: amiodarone - 1-6 months expectorants - 2 weeks Lugol solution - 3 weeks saturated solution of potassium iodine - 3 weeks vitamins - 10-14 days iodide-containing X-ray contrast agents - up to 1 year lithium - 4 weeks phenylbutazone - 1-2 weeks sulfonamides - 1 week thyroid hormones (natural or synthetic), e.g.: thyroxine - 4 weeks tri-iodothyronine - 2 weeks tolbutamide - 1 week topical iodide - 1-9 months (1,2)	ADREVIEW, HICON, JEANATOPE, MEGATOPE, SODIUM IODIDE I-123, SODIUM IODIDE I-131
Iobenguane I 123/Agents that Affect Catecholamines SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Many compounds that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells.(1) CLINICAL EFFECTS: Compounds that reduce catecholamine uptake or that deplete catecholamine stores may interfere with imaging completed with iobenguane.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Discuss the use of agents that affect catecholamines. Discontinue drugs that reduce catecholamine uptake or deplete catecholamine stores prior to imaging with iobenguane. Before imaging with iobenguane, discontinue agents that affect catecholamines for at least 5 biological half-lives, as clinically tolerated.(1) DISCUSSION: Many agents may reduce catecholamine uptake or deplete catecholamine stores.(1) Examples include: - CNS stimulants or amphetamines (e.g. cocaine, methylphenidate, dextroamphetamine) - norepinephrine and dopamine reuptake inhibitors (e.g. phentermine) - norepinephrine and serotonin reuptake inhibitors (e.g. tramadol) - monoamine oxidase inhibitors (e.g. phenelzine, linezolid) - central monoamine depleting drugs (e.g. reserpine) - non-select beta adrenergic blocking drugs (e.g. labetalol) - alpha agonists or alpha/beta agonists (e.g. pseudoephedrine, phenylephrine, ephedrine, phenylpropanolamine, naphazoline) - tricyclic antidepressants or norepinephrine reuptake inhibitors (e.g. amitriptyline, bupropion, duloxetine, mirtazapine, venlafaxine) - botanicals that may inhibit reuptake of norepinephrine, serotonin or dopamine (e.g. ephedra, ma huang, St. John's Wort, yohimbine)	ADREVIEW
Mixed;Indirect Sympathomimetics/Rasagiline SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Catecholamine stores increased by MAOIs can be released by indirect acting sympathomimetics such as ephedrine and amphetamine. MAO inhibitors also interfere with gut and liver metabolism of direct acting sympathomimetics (e.g oral phenylephrine). CLINICAL EFFECTS: Concurrent use of MAOIs may result in potentiation of sympathomimetic effects, which may result in headaches, hypertensive crisis, toxic neurological effects, and malignant hyperpyrexia. Hypertensive crisis has been reported in patients taking recommended doses of rasagiline with sympathomimetic agents. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: At recommended dosages, rasagiline is selective for MAO-B; however, at higher dosages it has been shown to lose its selectivity. Patients receiving higher dosages of rasagiline should be considered susceptive to this interaction. Concurrent use should be approached with caution. DISCUSSION: Indirect acting sympathomimetic amines may cause abrupt elevation of blood pressure when administered to patients taking monoamine oxidase inhibitors, resulting in a potentially fatal hypertensive crisis. Mixed (direct and indirect) acting sympathomimetics have also been shown to interact with monoamine oxidase inhibitors depending on their degree of indirect action. The direct-acting sympathomimetics have not been reported to interact. Dopamine is metabolized by monoamine oxidase, and its pressor effect is enhanced by monoamine oxidase inhibitors.	AZILECT, RASAGILINE MESYLATE

There are 3 moderate interactions. The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.

Drug Interaction	Drug Names
Sympathomimetics (Direct, Mixed-Acting)/Guanethidine SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Direct or mixed-acting sympathomimetics may inhibit uptake of guanethidine at the adrenergic neuron. CLINICAL EFFECTS: Decreased antihypertensive effectiveness. Effects may be seen for several days after discontinuation of the direct or mixed-acting sympathomimetic. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Avoid concomitant administration of these drugs. If both drugs are administered, adjust the guanethidine dose as needed based on blood pressure. DISCUSSION: Documentation supports routine monitoring of this interaction. It should be noted that this interaction can occur quickly.	GUANETHIDINE HEMISULFATE
Sympathomimetics/Rauwolfia Alkaloids SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Reserpine depletes catecholamine stores within the peripheral vascular adrenergic nerve endings, thus indirect acting sympathomimetics are unable to trigger the release of catecholamines. The reserpine-induced catecholamine release increases sensitivity to the effects of direct acting sympathomimetics. CLINICAL EFFECTS: Increased effects of direct acting sympathomimetics. Decreased effects of indirect acting sympathomimetics. Mixed acting sympathomimetics will show effects based on the predominance of either direct or indirect activity. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: If these agents are administered concurrently, monitor blood pressure. The dose of the sympathomimetic may need to be adjusted. DISCUSSION: This interaction has been well documented in animal studies and human case reports have confirmed the interaction. Reserpine has been shown to decrease the response to epinephrine administered for hypotension. Reserpine has also been shown to decrease the effectiveness of ophthalmic epinephrine, a direct acting sympathomimetic. Ophthalmic phenylephrine has been shown to decrease the hypotensive effects of reserpine.	RESERPINE
Sympathomimetics (Direct, Mixed-Acting)/Methyldopa SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Unknown. CLINICAL EFFECTS: The pressor response to sympathomimetics may be increased. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Start with low doses of sympathomimetics and monitor blood pressure of patients during concurrent administration of sympathomimetics and methyldopa. DISCUSSION: The pressor response to sympathomimetics has been reported to be increased during methyldopa administration. In addition to increased duration of pressor response, severe hypertension has been reported.	METHYLDOPA, METHYLDOPA-HYDROCHLOROTHIAZIDE, METHYLDOPATE HCL

The following contraindication information is available for ALLERGY RELIEF D12 (loratadine/pseudoephedrine sulfate):

Overview
Contraindicated
Severe
Moderate

Drug contraindication overview.

No enhanced Contraindications information available for this drug.

There are 3 contraindications. Absolute contraindication.

Contraindication List
Severe coronary artery disease
Severe uncontrolled hypertension
Urinary retention

There are 6 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Angle-closure glaucoma
Benign prostatic hyperplasia
Diabetes mellitus
Hypertension
Hyperthyroidism
Pheochromocytoma

There are 5 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Disease of liver
Hepatic failure
Kidney disease with reduction in glomerular filtration rate (GFr)
Renal disease with moderate to severe function impairment
Severe hepatic disease

The following adverse reaction information is available for ALLERGY RELIEF D12 (loratadine/pseudoephedrine sulfate):

Overview
Severe
Less Severe

Adverse reaction overview.

No enhanced Common Adverse Effects information available for this drug.

There are 12 severe adverse reactions.

More Frequent	Less Frequent
None.	None.

Rare/Very Rare
Abnormal hepatic function tests Acute generalized exanthematous pustulosis Anaphylaxis Angioedema Dyspnea Hallucinations Hypertension Ischemic colitis Posterior reversible encephalopathy syndrome Reversible cerebral vasoconstriction syndrome Seizure disorder Vomiting

There are 58 less severe adverse reactions.

More Frequent	Less Frequent
Headache disorder Insomnia

Rare/Very Rare
Abdominal pain with cramps Acute cognitive impairment Alopecia Anticholinergic toxicity Blurred vision Bronchitis Cardiac arrhythmia Chest tightness Concentration difficulty Cough Dizziness Dream disorder Dry nose Dry throat Dyspepsia Dyspnea Earache Epistaxis Excitement Fatigue Gastritis Hyperhidrosis Hyperkinesis Increased appetite Insomnia Malaise Nausea Nervousness Palpitations Pharyngitis Sedation Skin photosensitivity Skin rash Symptoms of anxiety Syncope Tachycardia Tinnitus Urinary incontinence Urinary retention Visual changes Voice change Weight gain Xerostomia

Rare/Very Rare

Abdominal pain with cramps
Acute cognitive impairment
Alopecia
Anticholinergic toxicity
Blurred vision
Bronchitis
Cardiac arrhythmia
Chest tightness
Concentration difficulty
Cough
Dizziness
Dream disorder
Dry nose
Dry throat
Dyspepsia
Dyspnea
Earache
Epistaxis
Excitement
Fatigue
Gastritis
Hyperhidrosis
Hyperkinesis
Increased appetite
Insomnia
Malaise
Nausea
Nervousness
Palpitations
Pharyngitis
Sedation
Skin photosensitivity
Skin rash
Symptoms of anxiety
Syncope
Tachycardia
Tinnitus
Urinary incontinence
Urinary retention
Visual changes
Voice change
Weight gain
Xerostomia

The following precautions are available for ALLERGY RELIEF D12 (loratadine/pseudoephedrine sulfate):

Pediatric
Pregnant
Lactation
Geriatric

No enhanced Pediatric Use information available for this drug.

Contraindicated

Pseudoephedrine (SR or High Dose)

1 Day – 12 Years

Increased sensitivity to side effects. Dose form or strength not appropriate.

Severe Precaution

None

Management or Monitoring Precaution

Loratadine

1 Day – 2 Years

Consult clinician for use age under 2 years. Safety and efficacy not established.

An increased incidence of hypospadias in male infants born to women who received loratadine during pregnancy was reported in one study. However, analysis of data from the National Birth Defects Prevention Study (NBDPS) indicated that use of loratadine during early pregnancy was not associated with an increased risk of second- or third-degree hypospadias. In addition, in 2 small prospective cohort studies that surveyed pregnant women who contacted a teratology information service, use of loratadine during the first trimester of pregnancy was not associated with major congenital anomalies and did not affect the rate of live birth, gestational age at birth, and birth weight.

Despite these findings, it should be noted that interpretation of these results is limited by the statistical limitations of the studies (i.e., small sample size, inadequate power, reliance on patient recall of drug use, exclusion criteria). The 2 prospective cohort studies were powered to detect statistical significance only if a substantial (i.e., approximately threefold) increase in the overall rate of major congenital anomalies was observed; the study that relied on NBDPS data excluded first-degree hypospadias because of the difficulty of detecting this mildest form in routine surveillance, making it difficult to determine the relationship between loratadine and this form of hypospadias. Thus, while these data may be useful, further study is needed to completely rule out the teratogenic risk of loratadine.

Because there are no adequate and controlled studies to date using loratadine in pregnant women, loratadine alone or in fixed combination with pseudoephedrine hydrochloride should be used during pregnancy only when the potential benefits justify the possible risks to the fetus. Reproduction studies in rats and rabbits using loratadine dosages up to 75 and 150 times, respectively, the maximum daily human dosage on a mg/m2 basis have not revealed evidence of harm to the fetus.

Drug/Drug Class	Severity	Precaution Description	Pregnancy Category Description
Pseudoephedrine	2	Limited human data are inconclusive on developmental toxicity risk	No fda rating but may have precautions or warnings; may have animal and/or human studies or pre or post marketing information.
Loratadine	B		Animal studies have failed to demonstrate a risk to the fetus but there are no well-controlled studies in pregnant women; or animal reproduction studies have shown an adverse effect (other than decrease in fertility), but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus during the first trimester of pregnancy (and there is no evidence of a risk in later trimesters).

Loratadine and desloratadine distribute readily into breast milk, achieving concentrations that are equivalent to those in plasma (i.e., a milk to plasma AUC ratio of 1.17 and 0.85, respectively). The manufacturer states that about 0.03% of a single 40-mg dose of loratadine was distributed into breast milk as loratadine and desloratadine over 48 hours.

Pseudoephedrine also distributes readily into breast milk. Caution should be exercised when loratadine is administered alone or in fixed combination with pseudoephedrine to a nursing woman, and a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman.

Precaution Exists
Precaution exists. (No data or inconclusive human data.) Use of this drug by breast feeding mothers should be evaluated carefully.

Drug Name	Excretion Potential	Effect on Infant	Notes
Loratadine	Excreted.This drug is known to be excreted in human breast milk.	It is not known whether this drug has an adverse effect on the nursing infant. (No data or inconclusive human data)	Limited data suggest low amounts excreted.
Pseudoephedrine	Excreted.This drug is known to be excreted in human breast milk.	This drug has been shown to have an adverse effect on the nursing infant.	May decrease milk supply and cause irritability

No enhanced Geriatric Use information available for this drug.

Precaution Exists
Geriatric management or monitoring precaution exists.

Drug Name	Narrative	REN	HEP	CARDIO	NEURO	PULM	ENDO
Loratadine	Neuro/Psych-Avoid in older adults with or at high risk for delirium because of inducing or worsening delirium.	N	N	N	Y	N	N
Pseudoephedrine	Cardiovascular-Elderly are more sensitive to tachycardia and hypertensive effects. May exacerbate symptomatic coronary insufficiency. Genitourinary-May cause urinary retention. Neuro/Psych-May worsen cognitive impairment in some elderly with dementia. Insomnia risk.	Y	N	Y	Y	N	N

The following icd codes are available for ALLERGY RELIEF D12 (loratadine/pseudoephedrine sulfate)'s list of indications:

Allergic conjunctivitis
H10.1	Acute atopic conjunctivitis
H10.10	Acute atopic conjunctivitis, unspecified eye
H10.11	Acute atopic conjunctivitis, right eye
H10.12	Acute atopic conjunctivitis, left eye
H10.13	Acute atopic conjunctivitis, bilateral
H10.44	Vernal conjunctivitis
H10.45	Other chronic allergic conjunctivitis
H16.26	Vernal keratoconjunctivitis, with limbar and corneal involvement
H16.261	Vernal keratoconjunctivitis, with limbar and corneal involvement, right eye
H16.262	Vernal keratoconjunctivitis, with limbar and corneal involvement, left eye
H16.263	Vernal keratoconjunctivitis, with limbar and corneal involvement, bilateral
H16.269	Vernal keratoconjunctivitis, with limbar and corneal involvement, unspecified eye
Allergic rhinitis
J30.1	Allergic rhinitis due to pollen
J30.2	Other seasonal allergic rhinitis
J30.5	Allergic rhinitis due to food
J30.8	Other allergic rhinitis
J30.81	Allergic rhinitis due to animal (cat) (dog) hair and dander
J30.89	Other allergic rhinitis
J30.9	Allergic rhinitis, unspecified
Cold symptoms
J00	Acute nasopharyngitis [common cold]
Nasal congestion
R09.81	Nasal congestion
Perennial allergic rhinitis
J31.0	Chronic rhinitis
Rhinorrhea
R09.82	Postnasal drip
Seasonal allergic rhinitis
J30.1	Allergic rhinitis due to pollen
J30.2	Other seasonal allergic rhinitis
Sneezing
R06.7	Sneezing
Vasomotor rhinitis
J30.0	Vasomotor rhinitis